Green Wave Analytical, LLC – FDA Warning Letter, Mar 7, 2022

The FDA issued a Warning Letter to Green Wave Analytical, LLC, a contract testing laboratory, following an inspection from February 15 to March 7, 2022. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the tested drugs adulterated.

Key violations include: 1. **Failure to validate test methods (21 CFR 211.165(e))**: The firm did not validate or verify test methods for accuracy, sensitivity, specificity, and reproducibility, including deviations from compendial methods without validation or system suitability checks. 2. **Incomplete laboratory records (21 CFR 211.194(a))**: Records lacked essential data such as method identification, execution documentation, identity of standards/reagents, sample lot numbers, and equipment used. 3. **Inadequate computer system controls (21 CFR 211.68(b))**: HPLC data acquisition systems lacked controls to prevent deletion or alteration of raw data, personnel had administrative privileges, audit trails were not activated, and electronic signatures were not validated. 4. **Failure to monitor environmental conditions (21 CFR 211.42(c)(10)(iv))**: The firm performed sterility testing without effectively monitoring environmental conditions for ISO 5 air quality or personnel. 5. **Inadequate quality unit (21 CFR 211.2