FDA 483 - Valisure, LLC - July 06, 2021

This FDA Form 483 details observations from an inspection of Valisure, LLC, an analytical lab located at 5 Science Park, New Haven, CT 06511 USA, conducted from May 26, 2021, to July 06, 2021. The inspection revealed significant deficiencies across laboratory systems, equipment qualification, data integrity, quality system, and compliance with the Drug Supply Chain Security Act (DSCSA).

**Key Observations:**

1. **Laboratory System - Inadequate Method Validation/Verification:** Valisure failed to adequately validate or verify analytical methods for pharmaceutical products, lacking documentation of the process, acceptance criteria, and validity evaluations. Specific examples include: * **ICP-MS Test (PR-021 R1):** Verification lacked justification for contaminant removal, evaluation of sample preparation for various dosage forms, and essential parameters like accuracy, precision, specificity, LOQ, range, and linearity. System suitability criteria were also absent or not followed. An unverified process was used to rule out lead-contaminated glass after an Out-of-Specification (OOS) lead result. * **GC-MS Impurity Test - Nitrosamines (PR-018 R4):** Verification was limited to Valsartan for NDMA/NDEA, but the method is used for other drug products and impurities without documented validation. System suitability requirements from the FDA method were omitted.