Drug factory · FDA FEI 3009395771

Sun Pharmaceutical Industries, Inc.

29 Dunham Rd, Billerica, MA, United States

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 18, 2025 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.
• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
• 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 cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Jun 29, 2016 inspection

• 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.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

Sep 17, 2014 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 followed.
• Test methods 21 CFR 211.165(e)
  The accuracy and specificity of test methods have not been documented.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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 processing of a drug product lack the training required to perform their assigned functions.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Apr 25, 2012 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of 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 and followed.
• Individual inventory record 21 CFR 211.184(c)
  Records fail to include an individual inventory record of each reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of drug product.
• Actual yield, % of theoretical yield 21 CFR 211.188(b)(7)
  The batch production and control records do not include a statement of the percentage of theoretical yield at appropriate stages of processing for each batch of drug product produced.
• 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.

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