Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for quality control and failure to provide corrective action documentation.
FDA inspectors also found that Sanapac did not prepare Master Production Records (MPRs) with Specifications for ingredients and finished batches throughout the production process. The records that were available did not comply with current Good Manufacturing Practices.
Additionally, Sanapac failed to keep Batch Production Records (BPRs) for labeled and packaged batches. The provided batch records did not adhere to the instructions and procedures of the master records.
From the Warning Letter sent by the FDA, inspectors found several violations of cGMPs related to manufacturing, packaging, labeling, and holding operations for dietary supplements. By failing to comply with 21 CFR Part 111, the batches are considered adulterated under section 402(g)(1) under the Federal Food, Drug, and Cosmetic Act (FD&C) (21 USC § 342(g)(1)).
Inspectors further uncovered unsubstantiated benefits from Sanapac’s website and found the company was also in violation of marketing unapproved new drugs. Products not recognized as generally recognized as safe (GRAS) are considered new drugs per section 201(p) of 21 USC 321(p). Without approval for new drugs, the drugs cannot enter the marketplace.
Sanapac failed to establish Specifications and In-Process tests to ensure the quality of label materials and packaging, in addition to failure to develop Specifications for finished batches. Specifications outline the identity, purity, strength, and composition standards for ingredients and batches.
Sanapac can mitigate further FDA action by implementing the corrective actions outlined in the Warning Letter. Further non-compliance can result in civil and criminal penalties levied by an injunction by the Department of Justice.
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