Inspections, Compliance, Enforcement, and Criminal Investigations
Consolidated Marketing Unlimited, Inc. 1/10/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 10, 2013
Consolidated Marketing Unlimited, Inc.
10873 NW 52nd Street, Suites 7-8
Sunrise, FL 33351-8000 U.S.A.
Dear Mr. Godin:
On April 23 through May 4, 2012, an investigator from the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 10873 NW 52nd Street, Suites 7-8, Sunrise, Florida. The inspection determined that your firm manufactures and distributes Cantron® (New Millennium Liquid Version and Advanced Scientific Capsule Version), GH-3, and Hydrazine Sulfate among other brand dietary supplements. The inspection also revealed serious violations of FDA’s Current Good Manufacturing Practice in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (CGMP), under 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 Act [21 U.S.C. § 342(g)(1)], in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You may find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
We received a response from you on May 21, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to you at the conclusion of the inspection. We address your response below.
Your inspection revealed the following violations:
- Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). For example, you did not conduct a test or examination of the dietary ingredients used in the following dietary supplements:
- Cantron® New Millennium Liquid Version (Lot #3211204) using dietary ingredients, Inositol (Lot #TR11177), Potassium Hydroxide (Lot #ZD0453), Sodium Sulfite (Lots #10392 and #92892), Pyrocatechol (Lot #001D8-C), and Cupric Sulfate (Lot #XN3024)
- Hydrazine Sulfate (Lot #HS3011244) using dietary ingredients, Hydrazine Sulfate (Lot #C040216) and Microcrystalline Cellulose (Lot #ZA0565)
At the time of inspection, you also stated that you had not tested the ingredients used in the manufacturing of Cantron and listed in the receiving log prior to use.
- You did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your master manufacturing record uses a blank form titled “Manufacturing and Production order” for the encapsulation and bottling of your Cantron® Advanced Scientific Capsule Version (ASV), Mild Silver Protein (MSP) and GH-3 products. This generic batch record form is used as needed and is filled out based on the previous batch record.
- You did not establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). For example, at the time of our inspection your Production Manager stated that the temperature thermometers and weight scales used in the manufacturing of Cantron Liquid lot #3210160 and lot #3211204 were not calibrated and that he did not know how to calibrate them. Also, the pH buffers used for calibrating the equipment had expired on March 2010 and July 2010. In addition, your Food Certified Manager who oversees daily operations told our investigator that they had not established written procedures for equipment controls such as calibration.
- You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of your dietary supplements to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, your firm lacks written procedures that cover your manufacturing, packaging and labeling, and holding operations.
- You failed to establish a specification for any point, step, or stage 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 [21 CFR 111.70]. You failed to establish specifications as follows:
- You did not establish specification for any point, step, or stage 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 [21 CFR 111.70(a)].
- You did not establish specifications for each component that you use in the manufacture of a dietary supplement to include a specification for identity of each component; specifications for purity, strength and composition of dietary supplements manufactured using the components are met; and establishing limits on those types of contamination that may lead to adulteration of the finished batch [21 CFR 111.70(b)].
- You did not establish specifications for in-process production of your raw material blends [21 CFR 111.70(c)].
- You did not establish labeling and packaging specifications for your dietary supplement [21 CFR 111.70(d)].
- You did not establish product specifications 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 [21 CFR 111.70(e)].
- You did not establish specifications for product received from your contract manufacturer to be packaged and labeled for distribution [21 CFR 111.70(f)].
- You did not establish packaging and labeling specifications to ensure that you use the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
- You did not establish and follow written procedures for fulfilling the requirements relating to the packaging and labels you receive, as required by 21 CFR 111.153. Specifically, you stated that you did not have any written procedures to meet the requirements (set forth in 21 CFR 111.160) that apply to the packaging and labels you received and used in the packaging and labeling of your Cantron® (New Millennium Liquid Version and Advanced Scientific Capsule Version), GH-3, Mild Silver Protein and Hydrazine Sulfate products. Furthermore, you did not have documentation that those requirements had been met [21 CFR 111.180(b)(3)].
- You failed to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing as required by 21 CFR 111.103. You do not have written procedures for the responsibilities of your quality control operations pertaining to the following areas:
- Representative samples and reserve samples [21 CFR 111.105(f) and (g)]
- Laboratory operations [21 CFR 111.110]
- Material review and disposition [21 CFR 111.113]
- Equipment, instruments and controls [21 CFR 111.117]
- Components, packaging and labeling [21 CFR 111.120]
- Master manufacturing batch production records and manufacturing operations [21 CFR 111.123]
- Release of packaged and labeled dietary supplements [21 CFR 111.123(a)(8)]
- Reprocessing [21 CFR 111.130]
- Returned dietary supplements [21 CFR 111.130]
- Your quality control personnel failed to conduct a material review and make a disposition decision when a batch deviates from the master manufacturing record (MMR), including when any step established in the master manufacturing record is not completed and including deviations from specifications, as required by 21 CFR 111.113(a)(2). You are required to make and keep documentation of any material review and disposition decision and follow-up [21 CFR 111.140(b)(3)]. Such documentation must meet the requirements of 21 CFR 111.140(b)(3), including an identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)]; a description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)]; an evaluation of whether or not the deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; the identification of the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CFR 111.140(b)(3)(iv)]; an explanation of what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].
Specifically, the following batches deviated from the MMR and you failed to provide documentation of any material review and disposition decision by quality control personnel:
- 4/23/12 Cantron capsules batch record lot #ASV12103EGEL-B180
- 4/23/12 Cantron capsules batch record lot #ASV12107EGEL-B180
- 4/23/12 Cantron capsules batch record lot #ASV12109EGEL-B180
- 4/23/12 Cantron liquid batch record lot #3210160
- 4/23/12 Cantron liquid batch record (lot # or date not recorded) with Stage I: step 8 occurring at (b)(4)
- 4/23/12 Cantron liquid batch record (lot # or date not recorded) with Stage I: Step 8 occurring at (b)(4)
- Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). The batch records that you provided to our investigators at the time of inspection did not include complete information related to production and in process controls used during production. Specifically, the Manufacturing and Production order used by your firm to document the production of your Mild Silver Protein (MSP) (Lots #12074B and #12068) dietary supplements batches were missing the following information:
- the identity of equipment used during batch production [21 CFR 111.260(b)]
- the date and time of maintenance, cleaning and sanitizing of the equipment used during production of the batch [21 CFR 111.260(c)]
- the actual results obtained during any monitoring operation [21 CFR 111.260(g)]
- the results of any testing or examination performed during the batch production [21 CFR 111.260(h)]
- documentation that the finished dietary supplement meets specifications established in accordance with 111.70(e) and (g) [21 CFR 111.260(i)]
- the initials of the person performing each manufacturing step and the person responsible for verifying the weight or measure of each component used in the batch, and for verifying the addition of components to the batch [21 CFR 111.260(j)]
- documentation, at the time of performance, of packaging and labeling operations [21 CFR 111.260(k)]
- documentation at the time of performance that quality control personnel performed its duties (i.e. reviewed the batch production record) [21 CFR 111.260(l)]
- documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)] and
- Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)]
In your response letter received by our office May 21, 2012, you state that “We intend to come into 100% compliance with the law and address and fix all of the observations noted….” You also state in your response that your certified food manager will be trained in Part 111 and upon graduation, “[W]e should have all issues fixed within 30-45 days.” To date, you have not provided our office any additional documentation so that we can ascertain the implementation of your proposed corrective actions; therefore we deem your response unacceptable.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility. It does not indicate that FDA conducted an all-inclusive review of all the products you manufacture and distribute. It is your responsibility to ensure that your firm is operating in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement CGMP regulations (21 CFR Part 111). You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 US.C. §§ 332 and 334].
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 re-inspection-related costs. A re-inspection 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 determining whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Salvatore N. Randazzo, Compliance Officer, at the address noted in the letterhead. Refer to the Unique Identification Number 344898 when replying. If you have questions, please contact Mr. Randazzo at 407-475-4712 or write him at the noted address.
Emma R. Singleton
Florida District Office