Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec 23. The inspection resulted in USFDA 483 with five observations. Observations include failure to review discrepancies thoroughly, deficiencies in procedures, cleaning and maintenance of equipment.
USFDA 483
- Failure to review discrepancies thoroughly: OOS investigations into failure of assay identified dilution error due to mix up of pipettes as root cause. The test procedure (STP) do not describes the pipettes to be used in the test; the CAPA did not revisit the STP failed to address the root cause.
- Quality system procedures are not fully in writing, followed
- Equipment used for testing of aluminium foil utilised in blister packaging was not qualified and not included in the equipment calibration program.
- Procedure is not established for calculating and rounding of the microbial CFU/ml results. No usage logbooks were in place for Colony counters in Microbiology lab.
- Critical alarms in the RABS/Dispensing was not documented and investigated as part of batch manufacturing record (BMR)
- Deficiencies in cleaning and maintenance of equipment – Cleaning agents to be used in cleaning of glassware washing machine in Microbiology lab are not defined in SOP, cleaning validation is not performed for the glassware washer, effectiveness of manual cleaning procedure is not verified. Observed rusting and dirt in the incubator in microbiology lab.. Condensation was observed in “cleaned and ready for use” glass bottles in glassware washing room. Worn gaskets were observed in capsule filling machine.
- For some components used in the manufacturing of drug products amount to be used in the batch are not defined and recorded (solution used in Capsule manufacturing)
- Deficiencies were observed in validation of test methods for Capsules.
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