Drug factory · FDA FEI 3003821988

Somerset Therapeutics Private Limited

54/1, Boodihal Village Nelamangala Taluk, 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.

Apr 4, 2022 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 written and 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.
• 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.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Jul 23, 2019 inspection

• 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.

Aug 20, 2013 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not followed that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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.
• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures and laboratory mechanisms are not justified.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures and laboratory control mechanisms are not 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 drug products conform to appropriate standards of identity, strength, quality and purity.
• Test methods 21 CFR 211.165(e)
  The accuracy and sensitivity of test methods have not been established.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning and use are not included in individual equipment logs.
• 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.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
• Written sanitation procedures lacking 21 CFR 211.56(b)
  There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the cleaning of equipment.

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