...Our investigator randomly selected folder 01/2014 from your electronic log, compared it to your firm’s official deviation logbook for 2014, and found that the deviations in the “GMP Anomalies” folder were not investigated or reported in the official deviation logbook.
Production deviations included, but were not limited to:
- out-of-limit temperature readings for critical process parameters
- incomplete batch records
- batch records pre-filled before manufacturing
- failure to record temperature, humidity, and pressure
- failure to add portions of raw materials during manufacturing
In your response, you attribute the root cause of these failures to deficient procedures and operators’ errors.Pre-filled batch records! That's a new one.