Drug factory · FDA FEI 3002809586

Sun Pharmaceutical Industries Limited

Halol-Baroda Highway, Halol, 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 13, 2025 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.
• 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 adequate validation of the aseptic process.
• 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.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• 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.
• 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 to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

May 9, 2022 inspection

• 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 adequate validation of the aseptic process.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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.
• 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.
• Aseptic Processing Area 21 CFR 211.42(c)(10)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• 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 to facilitate operations for its intended use and cleaning and maintenance.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Dec 13, 2019 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established and followed that describe the 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, 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 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 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.

Feb 23, 2018 inspection

• Aseptic Processing Area 21 CFR 211.42(c)(10)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures.

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