Drug factory · FDA FEI 3006785788

Ajanta Pharma Limited

B-4\5\6, MIDC Area, Paithan, Chhatrapati Sambhajinagar, 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.

Apr 21, 2026 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: manufacture.