Inspections, Compliance, Enforcement, and Criminal Investigations
James G. Cole, Inc. dba Maxam Nutraceutics 9/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
September 28, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-35
James G. Cole, President
James G. Cole, Inc., dba Maxam Nutraceutics
P.O. Box 1277
Hood River, Oregon 97031
Dear Mr. Cole:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 1020-D Wasco Street, Hood River, Oregon, from March 20, 2012, through March 23, 2012. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). At the conclusion of the inspection, your firm’s general manager was issued a Form FDA 483, Inspectional Observations, which listed a number of the violations that cause the dietary supplement products you manufacture 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 these products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We have received email responses on March 28, 2012, and March 30, 2012, and a written response dated April 19, 2012, from your firm’s general manager concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations. Your firm’s response to the Form FDA 483 is inadequate as you have not provided sufficient detail or documentation to demonstrate that your firm has made the necessary corrections in order to comply with these requirements.
The significant violations documented during the inspection include, but are not limited to, the following:
- Your firm failed to establish a master manufacturing record (MMR) in accordance with 21 CFR 111.205. Specifically, the only record you maintain titled “Mixing products” is not a unique record for each dietary supplement formulation and batch size your firm manufactures, and does not ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a). Furthermore, the “Mixing products” record does not include the basic requirement of identifying specifications for the points, steps or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and to specify the packaging and labeling of the dietary supplement in the MMR, as required by 21 CFR 111.205(b). Your “Mixing products” record may be used as part of your MMR because it documents written instructions as required by 21 CFR 111.210(h); however, you must include all elements from 21 CFR 111.210 in your MMR.
- Your firm failed to establish specifications, as required by 21 CFR 111.70. Specifically, you failed to establish specifications for components used in the manufacture of dietary supplements in accordance with 21 CFR 111.70(b). For example, your firm used the component “(b)(4)” to manufacture “PCA Enzyme Supplement With Probiotics,” but you failed to establish component specifications for this ingredient. Additionally, you failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). You provided our investigators with Certificates of Manufacture that are received with bulk product from your contract manufacturer for several of your products; however, the certificates do not include information that would assist in meeting the requirements under 21 CFR 111.70(e), i.e., product specifications for identity, purity, strength, and composition of the finished product. Once you have established specifications in accordance with 21 CFR 111.70, you must determine whether specifications that you establish are met in accordance with 21 CFR 111.73 and 21 CFR 111.75.
In your response dated April 19, 2012, you stated you receive a “finished” product from your (b)(4), and that all you do is (b)(4) that he sends to you. (b)(4) is a manufacturing step in the development of a finished product. Therefore, the product you receive from your biochemist is not a finished dietary supplement. Because you receive an in-process product to which you apply additional manufacturing steps, you must comply with the regulations for establishing component specifications in 21 CFR 111.70(b).
- Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm uses “(b)(4)” to manufacture “PCA Enzyme Supplement With Probiotics,” but you did not perform an identity test or examination of this dietary ingredient. As stated previously, the product that you receive from your (b)(4) is not a finished dietary supplement if you (b)(4) it. Rather, the product is a component, and specifically, it is a dietary ingredient. In your response dated April 19, 2012, you state that you will require a Certificate of Analysis from your biochemist and will also perform organoleptic testing as well. Because the product that you receive is a dietary ingredient, and not just a component, you may not rely on a Certificate of Analysis from the (b)(4), and you must perform at least one appropriate test or examination to verify the identity before you use the component. Organoleptic testing may not be an appropriate means of testing the identity of a (b)(4).
- Your firm failed to identify personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). You have not established 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 and 21 CFR 111.140(b)(1), nor have you documented the performance of any such quality control procedures as required by 21 CFR 111.140.
- Your firm failed to prepare a batch production record for each batch of dietary supplements manufactured, as required by 21 CFR 111.255, to include complete information relating to the production and control of each batch, and all of the required elements of a batch production record as listed in 21 CFR 111.260. Our investigators found that you failed to prepare batch production records with the exception of a “Mixing Log” used to assign lot numbers. The mixing log is inadequate in that it fails to include all elements in 21 CFR 111.260.
- Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Our investigators found that your firm did not collect and hold any reserve samples. We have reviewed your response dated April 19, 2012, but have found it to be inadequate because you failed to provide sufficient detail as to the steps you will take to fulfill the requirements to collect and hold reserve samples.
- Your firm failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503 and 111.535(b)(1).
The above violations are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. 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 all requirements of the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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 determine 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)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Within 15 working days of your 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 documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be sent to the following address: Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 302-0427.
Charles M. Breen