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
- 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.
- 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).