Drug factory · FDA FEI 3004086192

USV Private Limited

H-13, 16, 16A, 17, 18, 19, 20, 21 & E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman, 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.

Nov 17, 2022 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• In-process materials specifications testing 21 CFR 211.110(b)
  Examination and testing of samples is not done to assure that in-process materials conform to specifications.
• 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 and followed.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic process.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training and experience required to perform their assigned functions.

Aug 2, 2017 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.
• 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 components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(3)
  Establishment of the reliability of the closure supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Oct 14, 2012 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• 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: analysis; label; manufacture; pack; sterilize.