Drug factory · FDA FEI 3004536846

Apozeal Pharmaceuticals Inc

2091 Hartel St, Levittown, PA, 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.

Oct 15, 2025 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components 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 fully followed.
• 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.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Apr 9, 2019 inspection

• In-process conformity - examination, sample testing 21 CFR 211.110(b)
  Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
• 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 and followed.
• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and 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 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.
• 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 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.

Oct 27, 2009 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.
• 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.
• 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.
• 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 cleaning and maintenance.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
• 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the handling of components.

Registered with FDA for: analysis; manufacture; pack; relabel; repack.