Green Wave Analytical, LLC — FDA Warning Letter Findings

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records did not include complete data to support the analysis performed. For example, laboratory records for the chemical and microbiological testing of drugs lacked the identification of the method used, documentation of a method’s execution, identity of standards, reagents, and test kits used, identification of the sample’s lot number for traceability, or equipment used (including, but not limited to, microbiological media, micro-pipette, and high performance liquid chromatography (HPLC) instrument). Reliability of data is compromised when there is a failure to maintain complete records of the conditions and data associated with all tests. Furthermore, the lack of complete data compromises the quality unit’s (QU) ability to exercise its function of ensuring compliance to applicable standards.

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). Your firm is a contract testing laboratory that performs chemistry and microbiological analysis of drug components (ingredients), injectable drugs, and ophthalmic drugs. Your firm failed to perform method validation (or verification, as appropriate) of test methods to ensure that they were suitable for their intended use. For…

Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv). Your firm performed sterility testing for over (b)(4) lots of finished drug products purported as sterile but failed to effectively establish a system for monitoring environmental conditions to ensure ISO 5 air quality within the testing equipment and in adjacent areas. You also did not establish a system for monitoring of personnel who performed drug sterility testing. Your testing laboratory was also deficient in that it did not employ adequate facilities and controls to assure robust conditions for sterility testing. Poor or deficient sterility test facilities or controls can result in inaccurate data used by customers in determining final drug product batch disposition. The validity of results obtained under deficient testing conditions should be thoroughly evaluated.

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your QU did not adequately exercise its authority and responsibilities, including but not limited to, effective procedures and oversight. For example, your written procedures did not address QU oversight and responsibilities including the authority to review laboratory records…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked sufficient controls over your HPLC data acquisition systems used in the testing of drugs for release. For example, your (b)(4) Series HPLC instrument did not have sufficient controls to prevent deletion and alteration of raw data files…