FDA WARNING_LETTER - Shree Jaya Laboratories - September 12, 2024

The FDA issued a Warning Letter to Shree Jaya Laboratories PVT. LTD. following an inspection from September 4-12, 2024, identifying significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering their APIs adulterated.

Key violations include: 1. **Failure to clean equipment and facilities:** Equipment labeled "Cleaned" was found with excessive residues (e.g., (b)(4) #B-(b)(4)-404, (b)(4) #BI/(b)(4)). Building structures, like a ceiling above (b)(4) outside Production Block-(b)(4), were in disrepair with stains, cracks, and fallen plaster. The company's response, citing dedicated equipment and planned repairs, was deemed inadequate as it didn't address product carryover risks, personnel signing off on unclean equipment, or provide evidence of repairs. 2. **Inadequate investigation of quality-related complaints:** A complaint of (b)(4) particles in an intermediate was insufficiently investigated, failing to extend to other batches or consider environmental factors. Despite a CAPA for more frequent (b)(4) bag changes, the (b)(4) in Production Block – (b)(4) was observed to be in disrepair, corroded, and exposed to the environment with rust and a dead insect. The company's response, while providing an addendum, was inadequate