FDA WARNING_LETTER - Indoco Remedies Limited - January 25, 2019

The FDA issued a Warning Letter to Indoco Remedies Limited (Plant I) in Goa, India, following an inspection from January 17-25, 2019, citing significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Incomplete Batch Production Records (21 CFR 211.188):** Compression machine process control values (e.g., compression force, filling depth, automatic weight control) were inadequately reported in batch records for tablets intended for the U.S. market. Handwritten values often differed significantly from electronic data recorded by the programmable logic controller (PLC), with the quality unit releasing batches based on deficient records. Previous inspections also noted similar discrepancies. The firm's response was deemed insufficient for not committing to a comprehensive retrospective data integrity evaluation or adequately detailing process control procedures. 2. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The investigation into batch record discrepancies for tablets was insufficient, lacking a thorough root cause analysis for high variability in process parameters and failing to assess the impact of atypical values on batch quality. The firm acknowledged staff believed it was acceptable to overlook aberrant equipment control values if key tablet attributes were within specification. 3. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The