Drug factory · FDA FEI 1219540

Tower Laboratories Ltd

8 Industrial Park Road, Centerbrook, CT, 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.

Jul 30, 2025 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• 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.
• 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.

Mar 23, 2018 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.
• Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
  Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.

Jun 18, 2013 inspection

• Examination, testing; scientifically valid 21 CFR 111.320(b)
  You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.
• Examination, testing; scientifically valid 21 CFR 111.320(b)
  You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.
• Specifications not met - reject, quality control 21 CFR 111.77(a)
  Your quality control personnel did not reject a component and dietary supplement for which a specification was not met.
• Specifications not met - reject, quality control 21 CFR 111.77(a)
  Your quality control personnel did not reject a component and dietary supplement for which a specification was not met.
• 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.
• 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.
• Mixing adequacy 21 CFR 211.110(a)(3)
  The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
• Mixing adequacy 21 CFR 211.110(a)(3)
  The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written, and followed.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written, and followed.
• Reprocessing procedures not written or followed 21 CFR 211.115(a)
  Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written and followed.
• Reprocessing procedures not written or followed 21 CFR 211.115(a)
  Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written and followed.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of specifications including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of specifications including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Test methods 21 CFR 211.165(e)
  The reproducibility of test methods have not been established and documented.
• Test methods 21 CFR 211.165(e)
  The reproducibility of test methods have not been established and documented.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to reject all drug products.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to reject all drug products.

Mar 15, 2012 inspection

• Quality control operations - material review, disposition 21 CFR 111.113
  You do not have quality control operations for a material review and disposition decision.
• Quality control operations - material review, disposition 21 CFR 111.113
  You do not have quality control operations for a material review and disposition decision.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: label; manufacture; pack.