Aspire Pharmaceuticals, Inc. – FDA Warning Letter, Feb 3, 2022

The FDA issued a Warning Letter to Dr. Pai following a joint inspection of their dietary supplement and drug manufacturing facility from November 2021 to February 2022. The inspection revealed significant violations of Current Good Manufacturing Practice (cGMP) for both dietary supplements (21 CFR Part 111) and human drugs (21 CFR Parts 210 and 211), rendering the products adulterated.

For dietary supplements, violations included failure to use appropriate, scientifically valid methods for finished product testing (e.g., using "(b)(4)" for strength verification, unverified reference samples for FTIR identity testing, and lacking suitability testing for microbial methods across all products). Additionally, the firm's quality control failed to conduct material reviews and make disposition decisions for out-of-specification (OOS) results, instead retesting until a passing result was obtained without investigation. One dietary supplement product was also misbranded due to an incorrect serving size declaration.

For human drugs, significant violations included failure to ensure laboratory records contained complete data, with analysts routinely recording raw data in unofficial notebooks and altering sample weights to meet specifications, leading to the release of non-conforming batches. The firm also failed to establish sufficient specifications and analytical testing procedures for critical quality attributes, such as testing for the 4-aminophenol impurity in acetaminophen-containing products. Furthermore, the firm failed to thoroughly investigate unexplained discrepancies or failures, including performing unauthorized "trial" injections on