Inspections, Compliance, Enforcement, and Criminal Investigations

Sanapac Co., Inc. 3/24/17

 

  

Black HHS-Blue FDA Logo

 

 

 
PHILADELPHIA DISTRICT
U.S. CUSTOMHOUSE
2ND AND CHESTNUT STREETS
ROOM 900
PHILADELPHIA, PA 19106
TELEPHONE: 215-597-4390 

 

WARNING LETTER
17-PHI-07
 
 
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
March 24, 2017
 
Mrs. Darlene Doble, President
The Sanapac Company, Inc.
524 Orange Road
Dallas, Pennsylvania 18612
 
Dear Mrs. Doble:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 524 Orange Road, Dallas, Pennsylvania, from November 28 - 29, 2016 and December 1 & 6, 2016. Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111. 
 
Additionally, the agency reviewed your website at the Internet address www.sanapac.com the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov. and has determined that you take orders there for the products Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products. The claims on your website and in your product pamphlet that accompanies your shipments, establish that
 
Unapproved New Drugs
 
The FDA reviewed your website at the internet address www.sanapac.com, and your product pamphlet, which accompanies each shipment to customers. The claims on your website and other product labeling establish that the below products are drugs under section 201(g)(1)(B) of the Act, [21 U.S.C. § 321(g)(1)(B)], in that they are intended for use in the cure, mitigation, treatment, or prevention of disease. The below is not an all-inclusive list.
 
All products 
  • “Vitamin A- (Beta Carotene)…repair of body tissues. It helps maintain smooth, soft skin and helps protect the mucous membranes of the mouth, nose, throat and lungs, thereby reducing susceptibility to infections. Current medical research shows that foods rich in Beta Carotene may help reduce the risk of lung cancer, certain oral cancers and is known to have beneficial effects on vision.”
  • “VITAMIN B-3- (NIACIN)…lowering cholesterol levels…It is also involved in controlling blood sugar levels…”
  • “VITAMIN B-12…helping to prevent anemia…”
  • “VITAMIN C… helps heal wounds, scar tissue and fractures, builds resistance to infections, aids in the prevention and treatment of the common cold... It may decrease the risk of some cancers.” 
Inner Man and Inner Man Gold
  • “SARSAPARILLA…is an important aid for cystitis and renal colic from kidney stones. It is also used in the treatment of eczema…dermatitis and psoriasis.”
Inner Women
  • “BLACK COHOSH…It has anti-inflammatory and antispasmodic actions that can be used to help treat painful periods.”
  • “WILD YAM…It has antispasmodic and anti-inflammatory effects that may help ease menstrual pain.” 
Inner Man Gold, Inner Man, and Rooster Kings 
  • “SAW PALMETTO-…treating disorders of the urinary tract. It has also been employed to relieve persistent coughs….”
Inner Man Gold, Inner Man, and Inner Women
  • “POTASSIUM…stimulates the kidneys to eliminate poisonous body wastes and assists in reducing high blood pressure.”
Your products are not generally recognized as safe and effective for the referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
Adulterated Dietary Supplements
  1. You failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70. Specifically,
    1. You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come into contact with the dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement as required by 21 CFR 111.70(d). Specifically, you have no specifications for dietary supplement labels and packaging for the labeling and packaging operations you perform for your dietary supplement products.
    2. You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, although your firm creates the formulations that your contract manufacturer manufactures on your behalf, you have no specifications for any of your dietary supplement formulations for the identity, purity, strength, and composition, or limits on those types of contamination that may adulterate, or may lead to adulteration for the finished batch of dietary supplements received from your co-manufacturer.   
We note that your firm creates and changes formulations that (b)(4), as a co-manufacturer, manufactures on your behalf. You also receive finished batches of dietary supplements that your firm packages and labels for distribution under your firm’s name.
 
To the extent that you contract with other firms to manufacture your product that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements[1].  In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)]. 
  1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, during the inspection our investigator observed that that you did not have any procedures for the quality control inspection of your Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products received for repackaging and labeling at your facility. For example, there is no quality review and approval of your Procedure for Proper Operation of Pill Counter.
Once you have established your quality control written procedures, you must implement them into your packaging, labeling, and holding operations, as required by 21 CFR 111.65.
 
We acknowledge your response, dated December 14, 2016. You indicate that you have developed and follow written quality control procedures, and made provisions to chart and track labels, caps, and all items related to packaging your products. However, you provided no documentation of your corrective actions and we intend to verify the adequacy of your response in a future inspection. 
     
3.    You failed to prepare a master manufacturing record which identifies specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.205(b)(1). Specifically, your records for the repacking operations include the pill counter document and the labeling record. However, these records do not have the required specifications for your packaging and labeling processes.
 
4.    Your packaging and labeling batch production records fail to meet the requirements of 21 CFR 111.255. Specifically,
 
a.  You failed to prepare a batch production record every time you packaged and labeled a batch of a dietary supplement, as required by 21 CFR 111.255(a). Your Packaging Record (Procedure for Proper Operation of Pill Counter) and Labeling Record are not prepared for each unique batch of dietary supplement product that is packaged and labeled.  Your packaging record and Labeling Record include various dietary supplement products and lot codes.
 
b.  Your batch production records fail to include complete information relating to the production and control of each batch that is packaged and labeled, as required by 21 CFR 111.255(b). For example, your Packaging Record (Procedure for Proper Operation of Pill Counter) and Labeling Record does not include documentation, at the time of performance, of packaging and labeling operations required by 21 CFR 111.260(k). 
 
c.  Your batch production record fails to accurately follow the appropriate master manufacturing record, as required by 21 CFR 111.255(c). You provided the Procedure for Proper Operation of Pill Counter and Labeling Record as the batch record and the only document that your firm maintains to support your packaging and labeling operations.   For example, you do not have a master manufacturing record that contains specific actions necessary to perform and verify points, steps, or stages in the manufacturing process to ensure that the dietary supplement is packaged and labeled as specified in the manufacturing record (see 21 CFR 111.210(h)). Your batch record must accurately follow the appropriate master manufacturing record, as required by 21 CFR 111.255(c). 
 
5.    You failed to follow written procedures for fulfilling the requirement for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c).
 
Specifically, your procedure for Proper Operation of Pill Counter states verification of procedures being performed shall be recorded; however, you did not document the cleaning of the hopper, vibrating feed screen, and glass turntable each time a different product was packaged.
 
We acknowledge your response, dated December 14, 2016. You indicate that you have established charts for recording maintenance and cleaning procedures including your packaging area and all equipment used to distribute your products. However, you provided no documentation of your corrective actions and we intend to verify the adequacy of your response in a future inspection.
  1. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection, you did not have written procedures for holding and distributing your products, Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings.
We acknowledge your response, dated December 14, 2016; however, we find your response to be inadequate because you failed to address the need for written procedures for holding and distributing your dietary supplement products in your response.
  1. You failed to establish written procedures for fulfilling the requirements of personnel, as required by 21 CFR 111.8. Specifically, during the inspection you stated that you have no written procedures for hygienic practices or written procedures for the prevention of microbial contamination from sick or infected personnel.
We acknowledge your response, dated December 14, 2016. You indicate that you have established formal procedures regarding hygienic practices, such as using hair nets, gloves, lab coats, and sanitizing hands. Additionally, you indicate that face masks are also to be worn while packaging to prevent microbial contamination and that these procedures have been posted. However, you provided no documentation of your corrective actions and we intend to verify the adequacy of your response in a future inspection.
 
Misbranded Dietary Supplements 
 
Your dietary supplement products, Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings, are misbranded under Section 403 of the Act [21 U.S.C. § 343], in that they fail to comply with the labeling requirements for dietary supplements. Your label violations include the following:
  1. Your Inner Man, Inner Man Gold, and Inner Woman products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the
finished product labels fail to declare the major food allergen “ soy” as required by section 403(w)(1) of the Act.
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
    • The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
    • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, your Inner Man, Inner Man Gold, and Inner Woman product is manufactured using soy lecithin, which contains “soy.” 
  1. Your Inner Man product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)], in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as Ginseng Root (Eluethercocco). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. 
  1. Your Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)), in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example,
    1. The Inner Man and Inner Man Gold product labels declare “Potassium Gluconate;” however, this should be written as “Potassium (Potassium Gluconate).” [21 CFR 101.36(d)].
    1. The Inner Man and Inner Man Gold product labels declare potassium gluconate with a % Daily Value (DV); there is no established DV for this ingredient. However, there is a DV for potassium. [21 CFR 101.9 and 101.36(b) (3)].
    1. The Rooster Kings product label declares vitamin B-3 which is not the nomenclature specified in 21 CFR 101.9 or 101.36(b)(2)(i)(B) for niacin.
    1. The Inner Man, Inner Man Gold, and Inner Woman product label lists a % Daily Value for potassium that is in the incorrect increment and must bear "Less than 1%" or "<1%" when the quantitative amount by weight is great enough to require that the dietary ingredient be listed, but small enough to be zero when rounded to the nearest percent. [21 CFR 101.36(b) (2)(iii)(C)] .
    1. The Inner Man, Inner Man Gold, and Inner Woman product labels incorrectly contain a heavy bar below the “Amount per Serving” and “% Daily Value” headings in the extended right column listing of dietary ingredients [21 CFR 101.36(e)(7)].
    1. The Inner Man, Inner Man Gold, and Inner Woman product labels fail to place a heavy bar after the last (b)(2)-dietary ingredient. [21 CFR 101.36(e)(6)].
  1. Your Inner Man, Inner Man Gold, and Inner Woman products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example,
    1. The Inner Man and Inner Man Gold labels declare the dietary ingredients kelp and the Inner Man label declares muira puama, but does not state the correct corresponding Latin binomial as noted in the reference Herbs of Commerce.
    1. The Inner Man, Inner Man Gold, and Inner Woman labels declare the dietary ingredient kola nut and the Inner Man Gold label declares Golden Rod, but this is not a standardized common name noted in Herbs of Commerce.
    1. The Inner Man and Inner Woman labels declare the dietary ingredient Paba, but this is not the common or usual name for this dietary ingredient.
  1. Your Rooster Kings product is misbranded within the meaning of 403(r)(2)(A) of the Act [21 U.S.C. § 343 (r)(2)(A)], in that the label makes a claim stating the absence of a nutrient which is not in accordance with 21 CFR 101.13(e)(2). For example, your label claims “sugar and starch free” but does not indicate these dietary ingredients are not normally found in that type of product.
  1. Your Inner Man Gold and Rooster Kings products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
  1. Your Inner Man, Inner Man Gold, Inner Woman, and Rooster Kings products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)], in that the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
 
We offer you the following labeling comment: 
  • The product labels for your Rooster Kings products list “Crosscarmellose Sodium” as an ingredient. If your intent was to list Croscarmellose, the word is misspelled. 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentations. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your written response should be sent to Robin M. Rivers, Compliance Officer, at the address noted above. If you have any questions concerning this letter, please contact Ms. Rivers (215) 717-3076.
 
 
Sincerely,
/S/ 
Anne E. Johnson
District Director
Philadelphia District Office
 
 
cc: Pennsylvania State Department of Agriculture
       Bureau of Food Safety and Laboratory Services
       2301 North Cameron Street
       Harrisburg, PA 17110-9408  
       Attention: Dr. Lydia Johnson, Director      


[1]See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).

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