Drug factory · FDA FEI 1314625

Unither Manufacturing LLC

755 Jefferson Rd., Rochester, 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.

May 15, 2026 inspection

• 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, written and followed.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that in-process materials 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.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and 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.
• 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 and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy.

May 22, 2019 inspection

• Identity of major equipment and lines used 21 CFR 211.188(b)(2)
  Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
• 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Mar 1, 2017 inspection

• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Nov 23, 2010 inspection

• 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.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer and records or data are not checked for accuracy.

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