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FDA establishment 3003734940, West Chester, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 3
Last inspection ended: Mar 2, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 3 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 211.67(b). Written procedures not established/followed 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.
21 CFR 211.100(a). Absence of Written Procedures 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.
21 CFR 211.94(b). Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not representative of each lot or batch of drug product.
Voluntary Action Indicated (VAI)
Aug 10, 2023
Drugs · Drug Quality Assurance
6 cited references
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 211.130(e). Packaging line inspection before use Inspection of the facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
21 CFR 211.122(g)(3). Visual inspection The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for examination to be performed by one person and independently verified by a second person.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.186(b)(7). Theoretical yield statement including percentages Master production and control records lack a statement of theoretical yield.
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not representative of each lot or batch of drug product.
Voluntary Action Indicated (VAI)
Aug 12, 2021
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Mar 10, 2020
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.130(e). Packaging line inspection before use Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.67(b). Written procedures not established/followed 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.
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.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
Official Action Indicated (OAI)
Apr 27, 2018
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.100(a). Approval and review of procedures Written procedures are not reviewed and approved by the quality control unit.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.67(b). Written procedures not established/followed 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.
Official Action Indicated (OAI)
May 29, 2013
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
21 CFR 211.67(b). Written procedures not established/followed 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.
21 CFR 211.100(a). Approval and review of procedures Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
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
West Chester, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.