Findings
1Quality unit oversight
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). During the inspection of your facility our Investigator observed that your 2021 (b)(4) Tablets “PROCESS VALIDATION” report had data added, backdated signatures, and replaced pages. Your Quality Assurance Manager…
2Laboratory and QC controls
Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You did not use a United States Pharmacopeia (USP) method to test multiple drug products nor did you show equivalency or superiority for your alternate methods. For example, your E. coli test method for (b)(4) Solution and (b)(4) Tablets drug products only required sub-culturing if turbidity was observed. This differs from the USP method which…
3Data integrity
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 ultraviolet-visible (UV-Vis) spectrophotometer computer system lacked appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels. This UV-Vis system was used for release testing of drug…
About this record
Extracted automatically from the document US FDA published on 2024-10-08. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
