European Contract Manufacturers: Preparing for US client compliance expectations


Dean R. Cirotta
EAS Consulting Group, Alexandria, USA


For contract manufacturing operations located in Europe, that intend to supply dietary supplements to their clients for distribution in the US, it is imperative that they understand the current regulatory requirements that are set forth by both the FDA and their potential clients. Dietary Supplements are regulated products in the US under the FDA’s dietary supplement GMPS in 21 CFR Part 111. It is the US clients’ responsibility to ensure their contract partners are fully compliant with these regulations. This will be accomplished through initial assessments, on-site audits and contractual quality agreements. Contract manufacturers should be prepared to support these activities, have the necessary documentation readily available, and have staff well versed in the US requirements.

The United States Food and Drug Administration (USFDA) has made it clear, through 483 and warning letter observations, that if a company manufacturing dietary supplements for distribution into the United States, even as a contract manufacturer for another company, is fully responsible for ensuring that the dietary supplement manufactured and shipped is not adulterated due to a failure to comply with dietary supplement current Good Manufacturing Practices (cGMP) requirements. This means that each contract firm not only has a legal obligation to the USFDA but a contractual obligation to their clients, to ensure their contract manufacturing facilities are in full compliance with the requirements of 21 CFR Part 111 (1). The USFDA requires that dietary supplement distributors ensure that their products AND their contract manufacturing partners are in full compliance with all USFDA dietary supplement regulations. In addition to the client, the USFDA has the legal authority to inspect each registered manufacturing operation to ensure GMP compliance and to evaluate if the manufactured products meet their specifications, allowing them to be approved and released for distribution.

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