FDA establishment 3022250654, Exton, Pennsylvania, United States. Part of ProRx's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 2
Last inspection ended: Sep 19, 2025
Warning letters: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 classified OAI
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
12024Inspections1vs 2023+1
120252025Inspections1vs 2024+0
02026Inspections0vs 2025−1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
FDCA 503B(a)(10)(A): Drug product labels, fails to include2
FDCA 503B(a)(10)(A). Drug product labels, fails to include The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.192. Investigations of discrepancies, failures 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.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
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.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the quality of drug products.
Official Action Indicated (OAI)
Aug 2, 2024
Drugs · Drug Quality Assurance
13 cited references
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 and cleaning and maintenance.
21 CFR 211.28(a). Clothing appropriate for duties performed Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
FDCA 503B(b)(2)(A). Outsourcing facility, compounded drug report during registration Your outsourcing facility did not submit a report to FDA upon initial registration as an outsourcing facility identifying the drugs compounded during the previous six month period.
FDCA 503B(a)(10)(A). Drug product labels, fails to include The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.192. Investigations of discrepancies, failures 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.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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 211.113(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.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
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Exton, Pennsylvania, United States. Part of