Drug factory · FDA FEI 1319086

ONY Biotech Inc.

1576 Sweet Home Road, Amherst, 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.

Feb 5, 2026 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• 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.
• 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.
• 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.
• 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.

Sep 26, 2024 inspection

• 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.
• 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.
• 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.
• 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.
• 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.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• 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 free of infestation by rodents, birds insects, and other vermin.
• 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 free of infestation by rodents, birds insects, and other vermin.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing 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.
• 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 maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

Oct 9, 2015 inspection

• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Air filtration system lacking in production area 21 CFR 211.46(c)
  The production area air supply lacks an appropriate air filtration system.
• Air filtration system lacking in production area 21 CFR 211.46(c)
  The production area air supply lacks an appropriate air filtration system.

Oct 6, 2011 inspection

• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Failure by applicant to report ADE 21 CFR 314.80(c)
  Adverse drug experience information has not been reported to FDA.
• Failure by applicant to report ADE 21 CFR 314.80(c)
  Adverse drug experience information has not been reported to FDA.

Registered with FDA for: analysis; api manufacture; manufacture; sterilize.