SUBCHAPTER 2.7 - DETENTION ACTIVITIES
- 2.7.1 - OVERVIEW AND AUTHORITY
- 22.214.171.124 - OverviewContent
- 126.96.36.199 - Authorities
- 188.8.131.52 - Definitions
- 2.7.2 - INSPECTIONAL PROCEDURE
- 184.108.40.206 - Criteria for Detention
- 220.127.116.11 - Detention Procedure
- 18.104.22.168 - Detention Order ( Form FDA 2289)
- 22.214.171.124 - Detention Tag FDA 2290
- 126.96.36.199 - Termination of Detention
Detention protects the public by preventing movement in interstate or intrastate commerce of a food, device, or drug that an authorized FDA representative has reason to believe is adulterated or misbranded, while FDA institutes appropriate action. Administrative detention is implemented to gain immediate control over products when there is reason to believe the products are adulterated or misbranded. Such actions are designed for swift and immediate action to ensure that adulterated or misbranded products do not enter commerce or, if they are already in commerce, to stop them from reaching consumers. FDA may initiate seizure against detained foods, devices, and drugs, and/or injunction under sections 304(a) and 302 of the FD&C Act, respectively. In addition, FDA may consider instituting other action against detained foods, such as mandatory recall under section 423 of the FD&C Act, suspension of a food facility’s registration under section 415(b) of the FD&C Act, or emergency permit control under section 404 of the FD&C Act.
The specific statutory authorities, as well as specific set of guidelines that apply to a food, device, or drug are outlined in this section of the IOM1. The detention of a food, device, or drug will depend on the product involved; the situation and evidence observed or collected; and the statutory authority for the detention.
A food, device, or drug in "domestic import" as well as "import status" could be detained as described in this subchapter provided they meet the criteria listed below. Generally, however, we will use our import detention authority to detain foods, devices, and drugs in import status. Import detention is covered separately in IOM Chapter 6 - Imports.
Accomplishing a Detention can take one or more paths depending on the product involved and the statute that applies. The applicable statutes and implementing regulations are explained in the "Authorities" section of this subchapter. The FD&C Act provides the authority for administrative detention of foods in section 304(h) and devices and drugs in section 304(g) of the FD&C Act.
Other statutes, such as the Federal Meat Inspection Act18 (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act19 (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act20 (EPIA) (21 U.S.C. 1031 et seq.), provide the authority for detention of foods processed in a facility under dual jurisdiction of FDA and the U.S. Department of Agriculture (USDA).
Detention of devices that an authorized FDA representative has reason to believe are adulterated or misbranded can only be accomplished under one statutory path: FD&C 304(g) of the FD&C Act with implementing regulations set forth in 21 CFR 800.55.
Detention of food (human or animal) except for food exclusively regulated by USDA, that FDA has reason to believe is adulterated or misbranded can be accomplished under one statutory path: section 304(h) of the FD&C Act with implementing regulations set forth in 21 CFR part 1, subpart K17. FDA’s administrative detention authority applies to both foods offered for import and food in domestic commerce. FDA’s authority to administratively detain food under section 304(h) is separate and distinct from FDA’s authority to refuse admission of imported food under section 8018(a). Import detention applies to food offered for import into the U.S. which may be subject to refusal of admission.
Detention of foods that USDA regulates (i.e., meat, poultry, or processed egg products) at a dual-jurisdiction facility that meets the jurisdictional requirements of section 304 of the FD&C Act and for which there is reason to believe that such food is adulterated or misbranded can be accomplished under one of the following three statutory paths: sections 402 and 409(b) of the FMIA [21 U.S.C. 672], section 19 of the PPIA [21 U.S.C. 467], or sections 19 and 23(d) of the EPIA[21 U.S.C. 1048], respectively. Alternatively to detaining food that USDA regulates within a dual-jurisdiction facility, detention of foods that USDA regulates (meat, poultry, and processed egg products) CANNOT be accomplished when those products are inside a USDA-inspected facility. FDA does not have authority to administratively detain food that is within the exclusive jurisdiction of the USDA.
188.8.131.52.4 - DETENTION OF DRUGS
Detention of drugs that an authorized FDA representative has reason to believe are adulterated or misbranded can only be accomplished under one statutory path: FD&C 304(g) of the FD&C Act with implementing regulations set forth in 21CFR 1.980.
184.108.40.206.5 - DETENTION PROCEDURAL STEPS
The procedures to be followed in both ordering and terminating a detention differ depending on the applicable authority. You must consult with your supervisor before detaining any food from a dual jurisdiction facility under section 304 of the FD&C Act or under the detention authorities in FMIA, PPIA, and EPIA. Furthermore, you must have the approval of the District Director in whose district the article of food is located or an official senior to the District Director prior to detaining any food under section 304(h) of the FD&C Act. You must have the approval of the FDA District Director before detaining any device or drug under section 304(g).
This subsection provides information on FDA’s detention authorities. Pertinent sections of the FMIA, PPIA, EPIA, and FD&C Act, and FDA regulations pertaining to detention of devices, drugs, and foods, are printed on the reverse of page 1 of Form FDA 2289, Detention Order (IOM Exhibit 2-214).
Section 304(g) of the FD&C Act provides FDA with authority to detain a device or drug believed to be adulterated or misbranded. You should become familiar with this section and the regulations implementing this authority. See 21 CFR 800.55 and 21 CFR 1.980. At the present time, the device regulations apply only to devices intended for human use. See FD&C Act section 304(g) [21 U.S.C. 334 (g)].
Section 304(h) of the FD&C Act provides FDA with the authority to order the detention of any article of food that is found during an inspection, examination, or investigation under the FD&C Act, if FDA has reason to believe that such article is adulterated or misbranded. You should become familiar with this section of the FD&C Act and the implementing regulations in 21 CFR Part 1, Subpart K.
Federal Meat Inspection Act (FMIA) - Sections 402 and 409(b) provide the FDA with the authority to detain meat products subject to the FMIA, found outside an USDA inspected plant, if the FDA has reason to believe the products are adulterated or misbranded under the FD&C Act. The detention may not exceed twenty (20) days and the items detained shall not be moved by any person from the place of detention until released by the FDA representative.
Poultry Products Inspection Act (PPIA) -Sections 19 and 24(b) provide the FDA with the authority to detain poultry products subject to the PPIA found outside an USDA inspected plant, if the FDA has reason to believe the products are adulterated or misbranded under the FD&C Act. Detention may not exceed twenty (20) days and the items detained shall not be moved from the place of detention until released by the FDA representative.
Egg Products Inspection Act (EPIA) - Sections 19 and 23(d) provide the FDA with the authority to detain egg products subject to the EPIA, found outside an USDA inspected plant, if the FDA has reason to believe the products are in violation of the EPIA Act. Detention may not exceed twenty (20) days and the items detained shall not be moved from the place of detention until released by the FDA representative.
Section 201(h) of the FD&C Act [21 U.S.C. 321 (h)] defines a device as follows: "The term "device" *** means an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any primary intended purposes."
The term food as used in section 304(h) of the FD&C Act, is defined in section 201(f) of the FD&C Act22, as follows: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” In addition, a dietary supplement, as defined in section 201(ff) of the FD&C Act, is deemed a food within the meaning of the FD&C Act.
Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.
For the purpose of detention of food under section 304(h)(2) of the FD&C Act, the term “perishable food” means food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 calendar days under normal shipping and storage conditions. See 21 CFR 1.37724.
For FDA purposes, meat products and poultry products are defined as the carcasses of cattle, sheep, swine, goats, horses, mules, other equines, or domesticated birds, parts of such carcasses, and products made wholly or in part from such carcasses, except products exempted by U.S.D.A. because they contain a relatively small amount of meat or poultry products (e.g.; meat flavored sauces, pork and beans, etc.). Examine labels for USDA Shield or coding information to help determine if it is a USDA product.
The term "egg" means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea.
The term "egg product" means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in relatively small proportion or historically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as he may prescribe to assure the egg ingredients are not adulterated and such products are not represented as egg products. This would be done on a case by case basis by USDA.
Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] defines a drug as follows: The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the Unites States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such statement.
Direct attention to meat, poultry, or egg products only when found during your regular operations; instructed to do so in a Compliance Program Guidance Manual; following up on complaints; or, on other assignments as directed by your supervisor.
Administrative detention of food under section 304(h) of the FD&C Act should be considered only when FDA has reason to believe that the article of food is adulterated or misbranded. The detention order must be approved by the FDA District Director of the district in which the food is detained or an FDA official senior to such Director (21 CFR 1.391).
In evaluating whether FDA has reason to believe that the article of food is adulterated or misbranded for purposes of detention of food, consider a number of factors, including, but not limited to, the reliability and reasonableness of the evidence or information and the totality of the specific facts and circumstances involved.
The criteria listed below are for your guidance in judging whether or not the product or products should be detained. Detention should be considered when all of the requirements listed for the particular detention authority are met.
For detention of devices under section 304(g) of the FD&C Act25, the primary criteria are:
- You have reason to believe the device is adulterated or misbranded.
- There is no reasonable assurance the device will not be used, moved, altered, or tampered with in any manner before the FDA can take appropriate legal action.
- The device is intended for human use.
For detention of food under section 304(h) of the FD&C Act, the primary criteria are:
- The article meets the definition of food in section 201(f) of the FD&C Act.
- You have reason to believe that the article of food is adulterated or misbranded (if you believe that the food may also present a threat of serious adverse health consequences, immediately advise your supervisor of the situation so that the District can promptly notify CFSAN, CVM, and/or FDA’s Emergency Operations Center, as appropriate, for assessment of hazard(s)).
- The article of food is not a meat, poultry, or egg product inside a USDA-inspected facility. If the article of food is a meat, poultry, or egg product outside a USDA-inspected facility, consult with your supervisor.
If all of the above conditions are met, contact your supervisor and consider administrative detention.
- The article meets the jurisdictional requirements of section 304 of the FD&C Act30 and is in commercial channels.
- The article is located in a facility that does not have USDA meat or poultry inspection service.
- The article is intended for human food channels or could be readily diverted into such channels.
- FDA has reason to believe the article is adulterated or misbranded under the FD&C Act.
NOTE: For any contemplated detentions of meat and poultry based on adulteration under section 402(b) of the FD&C Act31 [21 U.S.C. 342 (b)], check with your supervisor. These detentions should be cleared with the Center for Food Safety and Applied Nutrition.
For detention of products subject to the Egg Products Inspection Act32 the requirements are:
- The article, whether or not in interstate commerce, is located in a facility that does not have USDA Egg Products Inspection Service.
- The article is intended for human food channels or could be readily diverted into such channels.
- There is reason to believe the article is in violation of the Egg Products Inspection Act.
For detention of drugs under section 304(g) of the FD&C Act, the primary criteria are:
- The article(s) meets the definition of drug in section 201(g)(1) of the FD&C Act.
- You have reason to believe the drug(s) are adulterated or misbranded.
After assuring that the criteria for detention are met, immediately advise your supervisor of the situation. The information you furnish should consist of that requested in blocks numbered 2, 4, 5, 7, 8, 10, 11, 13, 15, 19, 20, 21, 22, 24 and 26 on the Detention Order, FDA 2289. See IOM 220.127.116.113.
For detention of l devices and drugs under section 304(g) the District director in whose District the device or drugs involved are located must approve the detention order in writing. For articles of food under section 304(h) of the FD&C Act, the District Director in whose District the article of food involved is located, or an FDA official senior to such director, must approve the detention order in writing. If prior written approval is not feasible, prior oral approval must be obtained and confirmed in writing as soon as possible.
If the article of food to be detained is in-transit aboard a conveyance, e.g., railcar, truck, or ship, be aware that that detention of food aboard a conveyance may impact other activities of commerce that are dependent upon the ongoing operation of the conveyance.
FDA may allow the detained food to be removed from the conveyance to a storage facility. However, consult with your supervisor on this matter because the determination of whether the food can be moved from the conveyance to another location should be made based on considerations about the nature of the contaminant, security, preservation of the food, and accessibility to the food during the period of detention.
For all detentions, follow the guidance in IOM section 4.3.4 to determine when FDA may examine a package that is in the possession, control or custody of a common carrier. Guidance on resealing a conveyance is also found in IOM section 18.104.22.168.
When you have been authorized to place a detention proceed as follows:
- If the article is a food indicate the conditions that are to be maintained while the article is detained by checking the appropriate method in Block 28 on the Detention Order (Form FDA 2289). After a device, drug, or food is detained, it may not be moved unless specific procedures are followed. Consult your supervisor for guidance.
- For detention of food under section 304(h), determine the storage conditions required, e.g., refrigeration, and whether movement to another facility is necessary to either provide the storage conditions required or for security purposes. Consult your supervisor for guidance. Indicate conditions that are to be maintained while the article of food is detained in the “Remarks” section of the detention notice (block #26). If applicable, also indicate that the movement of the food to another facility during detention has been authorized in writing by an authorized FDA representative, pursuant to 21 CFR 1.380 and 1.381.
- Maintain surveillance on detained products, including the in-transit products, during their transfer and after the products are placed in storage if possible.
- Ensure the custodian (i.e., the person in possession of the article when detained) places or maintains the detained product under the proper storage conditions.
- If neither (a) nor (b) is possible, place product under detention and remove it to a proper storage facility. Notify the custodian of the place of storage (use block 16 on the FDA-2289) and advise your supervisor of the necessity for including this information in the letter to the custodian and/or owner of the article.
- Personally inform the immediate custodian, at the highest management level, that the article is under FDA detention. If the article is a device, inform the custodian that the record keeping requirements of 21 CFR 800.55(k)40 are in effect. If the article is a drug, inform the custodian that the record keeping requirements of 21CFR 1.980(k) are in affect.
- Prepare the Form FDA-2289, as instructed in IOM 22.214.171.124.1, and issue page 1, the original, to the custodian named. If the product is a device, a drug, or an article of food detained under section 304(h) of the FD&C Act, point out the appeal rights of the owner, of the article, which are listed on the back of Page 1 of the FDA-2289, and include the right to appeal with or without requesting an informal hearing.
- Affix Detention Tags, FDA-2290 to the article in a manner to assure visibility. If necessary, a label other than the Detention Tag may be used to identify an article(s) of food that has been detained, provided the label includes all the information listed on the current FDA-2290.
The Detention Order,(Form FDA 2289), is a pre-numbered five-part snap-out form, constructed and arranged to serve as the detention order as a report of the action and as a notice to the custodian of an opportunity for an informal hearing.
Print or type the information in the appropriate blocks of the Form FDA 2289. The first page blocks which must be filled for detentions of foods in accordance with 21 CFR 1.38241 are those numbered 1, 3, 6, 9, 10, 11, 12, 15, 16, 017, and 18. Indicate the name and title of the person who approved the detention order and the manner in which the approval was obtained in blocks #17 and 18. For devices or drugs, mark #24 and #26 as N/A. For meat, poultry or egg products not being detained under the authority of section 304(h) of the FD&C Act42, mark #17 and 18 as N/A. Block 2 should also be completed. Once page 1 is completed, signed, and issued to the custodian of the product, it becomes an official document and the detention period begins.
You should immediately complete the additional pages of the Form FDA 2289 (Pages 2 through 5) and submit them to your supervisor, for processing the action. Blocks to be filled in on these pages are items 13, 14 and 19 through 28. These blocks should be completed as appropriate (e.g. if samples were collected) or according to the product being detained (e.g. device, drug, or food) if the pertinent information can be readily determined. See IOM Exhibit 2-2.
Preparation of Page 1:
- DISTRICT ADDRESS, PHONE NUMBER, FAX NUMBER, NAME OF DISTRICT and the DISTRICT DIRECTOR’S E-MAIL ADDRESS – This may be typed in advance. For detention of articles of food, the FDA District Director’s email address and fax number must also be included in this block. For detentions under the FMIA, PPIA, and EPIA, this information should also be included.
- NAME OF CUSTODIAN - Obtain the name of the highest-ranking official of the firm at the place of detention and issue to the official. Page 1 of the Form FDA 2289 is to be issued to the person named in this block.
- DETENTION ORDER NUMBER - This is normally pre-stamped on each form. In the event that an electronic version of the form is used in the field, the detention number from a pre-printed detention form must be entered and the original pre-printed form bearing that number destroyed. Any correspondence or subsequent actions should reference this number.
- TITLE OF CUSTODIAN - Insert proper official title such as president, warehouse manager, etc. Do not use courtesy titles.
- TELEPHONE NO. - Insert the office telephone number, including area code.
- DATE AND HOUR DETAINED - Insert actual date and time you hand the original to the custodian. The period of detention begins when you issue the original to that person.
- FIRM NAME - Enter the legal name of the custodial firm.
- ADDRESS - Use complete street name, city, state and Zip Code of custodial firm.
- MAXIMUM DETENTION ______ DAYS - Enter "20" for detention of meat, poultry or egg products. Enter either "20" or "30", as instructed by your supervisor, for detention of devices under section 304(g) of the FD&C Act, for the detention of drugs under section 304(g) of the FD&C Act, or detention of articles of food under section 304(h) of the FD&C Act.
- NAME OF DETAINED ARTICLE – Provide a complete list of the detained articles. Use the complete name of the product as labeled, e.g., "Beef Pot Pies with mushrooms", not just "Pies"; "Dr. Z's Tongue Depressors", not just "device". If there is insufficient space to list all the detained articles, attach Administrative Detention Continuation Form FDA 2289c to provide a complete list of all detained articles, and indicate in Block 10 that this list is attached. Be sure to record the Administrative Detention Order number from the original FDA 2289 on the FDA 2289c to link the two forms.
- SIZE OF DETAINED LOT - Indicate number of cases or other type container or article and subordinate containers, e.g., 2000 cases/24/#2 cans, 250 half sides pork carcasses, 500/fore quarters veal, 95 crates/50 lbs. whole fryers, 25/30 lb. cans frozen eggs, etc.
- DETAINED ARTICLE LABELED - Quote enough labeling so the article can be positively identified. Include product numbers, lot numbers, serial numbers, control codes, grade marks, etc. Follow the instructions in #10 above about using the FDA 2289c if there is insufficient space for a complete list of the labels.
- REASON FOR DETENTION - Give a brief, general statement of the reasons for detention, i.e., describe the apparent violation and briefly list evidence available to substantiate it. In the case of detention of food under section 304(h) of the FD&C Act, include information supporting the Agency’s reason to believe the food is adulterated or, misbranded. If there are multiple reasons for the Agency’s belief, list all the reasons and indicate if any reasons apply to a specific article or articles. If needed, use Form 2289c, the Administrative Detention Continuation Form, and note that the reasons are provided in the attached continuation form, and state at the top of the text block on 2289c that “The articles identified below from Box 10 were detained for the following reasons:”
Keep in mind that any classified information supporting the detention of food must be protected from unauthorized disclosure in the interest of national security. Consult with your supervisor for the requirement to protect classified information according to Executive Order 12958. If the product is a device or drug, always state not only the section of the FD&C Act the device or drug is believed to violate, but the particulars of the violation as well. Discuss the reasons for detention with your supervisor when you obtain the permission to detain a device or drug. See page 3 of IOM Exhibit 2-2.
- DETAINED ARTICLE STORED AT - In most instances this will be the same as the custodial firm indicated in blocks 7 and 8. However, if the product has been moved to another location, enter the name and address of the firm and location where it finally comes to rest and will stay until the detention is terminated. Include any applicable conditions of transportation to the final storage locale. Once the product is detained, it is unlawful to move it without direct authority from FDA, except that devices may be moved and processed under 21 CFR 800.55(h)(2) pursuant to section 304(g)(2)(B) of the FD&C Act [21 U.S.C. 334 (g)(2)(B)] and drugs may be moved and processed under 21CFR1.980(h)(2) pursuant to section 304(g)(2)(B) of the FD&C Act [21 U.S.C. 334 (g)(2)(B)]. Articles of food detained under section 304(h) of the FD&C Act may only be moved if FDA approves a request to modify a detention order under 21 CFR 1.381(c).
- Name and title of person who approved the detention order.
- Indicate whether approval of the detention order was written or oral. If oral, you must obtain written confirmation of the approval as soon as possible. For detentions other than detention of food under section 304(h) of the FD&C Act, enter "N/A."
NAME OF FDA EMPLOYEE - Print or type.
SIGNATURE - Sign the form.
TITLE - Enter your title.
- STORAGE OF DETAINED ARTICLES – Identify the appropriate storage conditions for the detained articles by checking the box marked either N/A, frozen, refrigerated or ambient, and, if conditions other than those which are temperate related are necessary, mark “other” and provide explanation.
The blocks on pages 2 through 5 are identical and completion of these constitutes your report on the detention, unless directed otherwise by your supervisor.
- APPROXIMATE VALUE OF LOT - This is the wholesale or invoice value of the merchandise. Estimate if there is no documentary reference you can quote.
- SAMPLE NUMBER(S) - List numbers of any samples taken in connection with the detention.
- NAME AND ADDRESS OF THE ARTICLE(S) OWNER – This will probably be the same as the custodian’s. However they may differ in the case of public warehouses or consigned goods. Enter the name and address, including zip code, of the actual owner. In the case of detention of food, if the owner of the article can be readily determined, you must issue a copy of the detention order to the owner as well as the custodian listed in block #2.
- NAME AND ADDRESS OF INITIAL SHIPPER OR SELLER - Enter name and address of person or firm who first shipped or sold the product.
- NAME AND ADDRESS OF SUBSEQUENT SHIPPERS OR SELLERS - If products have passed through more than one firm prior to coming to your attention, list these firms and indicate transit points under their control.
- NAME OF CARRIERS - List carrier or carriers involved, starting with the one who first picked up the article and indicate transit points under their control.
- DATE LOT SHIPPED - Use date on a shipping document, not the invoice date.
- NAME AND ADDRESS OF PACKING PLANT - Enter firm name and address of the plant where products were actually packed, processed, manufactured or assembled. For devices, drugs or articles of food other than meat, poultry, and egg products, enter "N/A".
- DATE LOT RECEIVED - Date the article was received by the firm at the location where currently detained.
- PACKING PLANT USDA NO. - All plants under U.S. Department of Agriculture inspections are numbered. This number is placed on products packed or processed in that particular plant. Enter the complete number. For a device drug or article of food other than meat, poultry, and egg products, enter "N/A".
- DESCRIPTION OF SAMPLE - Describe sample(s) collected in connection with the detention operations. This will be the same as on the C/R.
REMARKS - Use FDA Form 2289c to elaborate on items wherever necessary. List any recommendations you made to the custodian for special storage such as refrigerated, frozen, etc.
Distribution of FDA-2289 - The five-part snap-out is distributed as follows:
- Page 1, original - Give to custodian and, if applicable, give a copy of page 1 to the owner of the article. Give the two-sided text page listing statutory references to the owner of the article.
- Page 2, 3, 4 - Turn in to your district immediately using the fastest means possible.
- Page 5 - Retain in your possession.
This tag is a warning and identification device intended to be affixed to the detained products.
As soon as you have issued the Detention Notice, fill out Detention Tags, FDA 2290, following the instructions below. See IOM Exhibit 2-3.
- "DETENTION DATE AND HOUR" - Copy the date and hour of detention from block #6 of the Detention Order (FDA Form 2289).
- "DETENTION Order NO. DO" - Copy the exact number from block #3 of the Detention Order.
- "MAXIMUM DETENTION _____ DAYS" - Copy the number of days from block #9 of the Detention Order.
- "NAME FDA EMPLOYEE WHO ISSUED DETENTION Order" - Print or type.
- "SIGNATURE" - Sign.
- "TITLE" - Enter your title.
- "NAME OF THE EMPLOYEE AFIXING TAG (if different from issuing employee)"
- "SIGNATURE OF EMPLOYEE AFIXING TAG (if different from issuing employee)"
- "TITLE OF EMPLOYEE AFIXING TAG (if different from issuing employee)"
- "NAME OF DETAINED ARTICLE" - Enter the name exactly as in Block #10 of Detention Order.
- "DETAINED ARTICLE LABELED" - Copy enough from Block #12 of Detention Order to identify the product.
- "SIZE OF DETAINED LOT" - Copy from Block #11 of Detention Order.
Complete and affix tags so they are visible on several sides of the lot detained. Use sufficient tags to give adequate warning the lot is under U.S FDA Detention and must not be used, moved, or tampered with, in any manner.
Each tag has a self-locking pin, the point of which should be firmly inserted in an appropriate seam, border, flap, or other area of the container or product, and pulled sharply downward to engage the top curve of the pin. Do not just lay tags on the articles. Secure them to the containers or products. If locking pin cannot be used, tape or tie the tag firmly onto the container or item.
Advise the custodian that Detention Tags have been affixed, and of the reason for the detention. Also advise the custodian that the merchandise may not be moved without written permission of the Agency. In-process devices may be completed without permission. For devices, see 21 CFR 800.55(h)(2)53 for instructions. For drugs, see 21CFR 1.980(h)(2) for instructions. For detention of foods, see 21 CFR 1.381(c)54.
When final action has been taken on the detention, you will be authorized to terminate the detention. This will occur when one of the following conditions has been met.
- For articles of food under detention, the article of food has been destroyed under appropriate supervision.
- For drugs or devices, the product has been brought into compliance or destroyed under appropriate supervision. For meat, poultry, or egg products detained under authority of the FMIA55, PPIA56, or EPIA57 the product has been brought into compliance, denatured or destroyed under appropriate supervision.
- For meat, poultry, and egg products detained under authority of the FMIA, PPIA, or EPIA, the USDA, state, county, or local authorities have accepted jurisdiction and control of the article.
- For meat, poultry, and egg products detained under authority of the FMIA, PPIA, or EPIA, it has been determined there is no significant violation of the FD&C Act, or of the EPIA, whichever is applicable, and the USDA has been notified that FDA intends to terminate the detention.
- Twenty calendar days have expired ( or, if an additional ten calendar day detention period has been ordered, thirty calendar days have expired), counting from the day and hour of detention of the product. In this circumstance, no action is necessary on the part of the District.
- A seizure action under section 304(a) of the FD&C Act has been instituted in court and the goods have been seized by the U.S. Marshals pursuant to a court issued warrant, or injunction action under section 302 of the FD&C Act has been instituted in Court.
- The district director or the Regional Food and Drug Director order the termination.
As soon as you are authorized to terminate the detention, proceed to where the detained material is stored, personally remove and completely destroy all detention tags. Do not merely throw them in the trash.
Issuance of Detention Termination Notice FDA 2291 - As soon as you have removed all detention tags, tell the custodian the article is no longer under detention. Immediately prepare a Detention Termination Notice by filling out blocks 1 through 12, and the bottom of the form to include name, title, and signature. Give the original (page 1) to the custodian. This terminates the detention.
Complete the "Remarks" section to elaborate on pertinent information such as supervision, reconditioning, destruction accomplished, etc. The Detention Termination Notice, FDA 2291, together with Detention Notice, FDA 2289, will, unless instructed otherwise, constitute the complete report on the detention. See IOM Exhibit 2-4.
Official samples of articles involved in this type of operation are collected, prepared, and submitted in the same manner as any other regulatory samples. In the case of food detained under Section 304(h) of the FD&C Act59, consult with your supervisor to determine whether the suspected contaminant in articles of food that have been detained makes it necessary to follow sampling procedures that may be different from those followed for routine regulatory samples.
Methods and procedures for reconditioning, denaturing, or destruction, will be proposed to the district by the owner of the devices , drugs, or meat, poultry, or egg products. For food detained under Section 304(h) of the FD&C Act60, destruction will likely be the only option, and it can only be done after FDA approves in writing a request to modify the detention order. For all detentions, do not take any action on reconditioning, denaturing, or destruction unless you are authorized by your supervisor. The district officials will determine the adequacy of the proposed method. If satisfactory, you will be advised of the procedure and authorized to monitor the action.
When the operation is satisfactorily completed, and when authorized, terminate the detention as indicated in IOM 126.96.36.199.261.
The results of the reconditioning, denaturing, or destruction may be described in the "Remarks" section on the Detention Termination Notice, FDA 2291, if desired. See IOM Exhibit 2-462.
Except in unusual situations, or unless instructed otherwise by your supervisor, the Detention Order, Form FDA 2289, the Detention Order Termination, Form FDA 2291, and the FACTS Collection Record are designed to provide all information required to report the action from detention to termination.