Drug factory · FDA FEI 2242327

Cetylite Industries, Inc.

9051 River Road, Pennsauken, NJ, 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.

Dec 9, 2024 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish 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 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.
• 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.
• 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.

Mar 2, 2023 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• 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.
• 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.

Sep 24, 2021 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed to assure that components, labeling 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.

May 29, 2018 inspection

• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• 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.
• 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.
• Inadequate number of personnel 21 CFR 211.25(c)
  The number of qualified personnel is inadequate to perform the manufacture, processing, packing and holding of each drug product.
• Inadequate number of personnel 21 CFR 211.25(c)
  The number of qualified personnel is inadequate to perform the manufacture, processing, packing and holding of each drug product.
• Status of Each Lot Identified 21 CFR 211.80(d)
  Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
• Status of Each Lot Identified 21 CFR 211.80(d)
  Each lot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
• Failure to develop written procedures 21 CFR 310.305(a)
  Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of postmarketing adverse drug experiences.
• Failure to develop written procedures 21 CFR 310.305(a)
  Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of postmarketing adverse drug experiences.
• Late submission 21 CFR 310.305(c)(1)(i)
  Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information.
• Late submission 21 CFR 310.305(c)(1)(i)
  Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information.

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