Drug factory · FDA FEI 3003813519

Onesource Specialty Pharma Limited

Sterile Product Division, Opp IIM, Bilekahalli, Bannerghatta Road, , 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.

Jun 30, 2026 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

Mar 28, 2024 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
• Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
  All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.

Dec 20, 2019 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Mar 13, 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.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• 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.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of for testing or examination.

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