Badrivishal Chemicals & Pharmaceuticals – FDA 483, Aug 19, 2016

The FDA Form 483 details significant deficiencies in quality control and manufacturing practices at a facility producing intermediates and APIs.

**Key Violations and Observations:**

* **Document Control:** Inadequate controls over document changes. No registers for original issuance of controlled documents (batch records, analytical reports, worksheets). No distinction between original and unauthorized copies, and no reconciliation of working copies. An uncontrolled, serialized stamp used for numbering logbooks was found in the QC Lab. * **Incomplete Laboratory Records:** Numerous torn, discarded records recovered from refuse showed discrepancies with official versions, including product names, solubility test data, water testing results (some indicating non-compliance while official records showed compliance), environmental monitoring (temperature/humidity), and equipment calibration records. No formal justification or investigation for these discarded records or unreported data. * **Incomplete Chromatographic Data:** Impurity testing data from a contract lab lacked complete information, such as full injection sequences, original/reprocessed data sets, and explanations for aborted sequences for multiple released batches. * **Unsound Laboratory Control Mechanisms:** Growth promotion testing of in-house media used only a single test organism, not compendial requirements. Media temperature was not monitored during preparation. Incubator temperatures were not recorded. * **Inadequate Computerized System Controls:** Shared Administrator user name and password for QC Lab computerized systems, allowing unrestricted deletion, modification, and alteration of raw chromatographic data. * **Undocumented Test