FDA WARNING_LETTER - Unimark Remedies Ltd. - March 21, 2014

On September 28, 2015, the FDA issued a Warning Letter to Unimark Remedies Ltd. following a March 18-21, 2014 inspection of their pharmaceutical manufacturing facility in India. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under the FD&C Act.

Key violations included: 1. **Failure to document activities contemporaneously:** Production and analytical testing records were not entered at the time of performance, with instances of backdated entries and incomplete water testing records. Management admitted records were created post-manufacturing. 2. **Lack of data integrity controls:** Laboratory systems lacked unique usernames, passwords, and user access levels, allowing all employees full privileges to delete or alter raw data, chromatograms, and time stamps. Many instruments also lacked audit trail functions. 3. **Failure to maintain complete data:** Essential chromatographic information (integration parameters, injection sequences) was discarded or overwritten, leading to reliance on incomplete records for API quality evaluation. Inconsistencies in stability sample data and undocumented testing were also noted. 4. **Poor facility maintenance and pest control:** Evidence of pests (bird's nest, bird feces, lizard) was observed in manufacturing and raw material areas, and the facility was not sealed against pests. The firm lacked written pest control procedures.

The FDA deemed the company's previous responses inadequate, citing a