FDA WARNING_LETTER - Posh Chemicals Private Limited - March 08, 2013

On August 2, 2013, the FDA issued a Warning Letter to Posh Chemicals Private Limited following a March 3-8, 2013 inspection of their pharmaceutical manufacturing facility in Hyderabad, India. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to protect computerized data:** No restrictions on access to laboratory data on standalone instrumentation (HPLCs, FTIR, GC), allowing alteration or deletion without audit trails. The firm claimed to be updating software but denied misconduct, despite investigator findings. 2. **Non-validated test procedures:** Use of non-validated assays for testing key starting materials and an intermediate in API manufacture. 3. **Failure to follow and document quality-related activities:** A QC Chemist admitted to recording false visual examination data in reserve sample logbooks under a senior colleague's direction. The firm also failed to note a trend of decreasing total impurity results in stability tests for an API.

The FDA requires a detailed summary of investigations into misconduct, data falsification, and the role of the senior colleague, along with plans for a thorough data integrity investigation across all personnel. The firm must submit method validation reports for all non-compendial analytical methods and a timeline