Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 1314625, Rochester, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 8
Official action indicated: 1
Last inspection ended: May 15, 2026
Warning letters: 0
Import refusals since 2024: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.67(b). Written procedures not established/followed 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.
21 CFR 211.165(d). Acceptance criteria for sampling & testing 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.
21 CFR 211.68(b). input/output verification Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
21 CFR 211.160(b). Scientifically sound laboratory controls 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.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Official Action Indicated (OAI)
Oct 15, 2021
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
May 22, 2019
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
21 CFR 211.188(b)(2). Identity of major equipment and lines used Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Mar 1, 2017
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
Voluntary Action Indicated (VAI)
Jun 1, 2015
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 15, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 23, 2010
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.68(b). input/output verification Input to and output from the computer and records or data are not checked for accuracy.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
Voluntary Action Indicated (VAI)
Jan 19, 2010
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Import Refusals
1 refused shipment lines since 2024, grouped by product and charges
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Rochester, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.