Drug factory · FDA FEI 3009310198

Micro Labs Limited

113-116, IV Phase, Jigani Link Road, KIADB, Bommasandra Industrial Area, Bengaluru, India

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 22, 2018 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Habits of good sanitation & health 21 CFR 211.28(b)
  Production personnel were not practicing good sanitation and health habits.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: analysis; label; manufacture; pack.