FDA WARNING_LETTER - Promed Exports Private Limited - April 03, 2013

This FDA Warning Letter, dated August 9, 2013, was issued to Promed Exports Private Limited (now Sentiss Pharma Pvt. Ltd.) following an inspection from March 25 to April 3, 2013. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Environmental Monitoring and Cleaning in Aseptic Areas (21 CFR 211.42(c)(10)(iv) and (v)):** The firm failed to conduct viable air monitoring inside the Class 100 (ISO 5) filling barrier on the (b)(4) Line (b)(4) under dynamic conditions. Additionally, a sporicidal disinfectant was not regularly used for cleaning inside Class 100 areas, despite a previous media fill failure identifying a spore-forming organism. The firm's response committed to revising EM procedures, re-establishing sampling locations, and using a sporicidal agent, but lacked sufficient detail and qualification reports.

2. **Failure to Thoroughly Investigate Discrepancies/Failures (21 CFR 211.192):** * The firm did not determine the root cause for (b)(4) clogging during product transfer for multiple