Drug factory · FDA FEI 3009963974

Advanced Pharmaceutical Technology, Inc.

132 S. Central Ave, Elmsford, NY, 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.

Aug 1, 2024 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.
• 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 sterilization process.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and held under contract by another company.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Aug 23, 2021 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.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perform their assigned functions.
• Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Registered with FDA for: label; manufacture; pack.