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FDA establishment 3001452536, Morrisville, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Nov 14, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.134(c). Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
Voluntary Action Indicated (VAI)
Aug 7, 2024
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance of equipment.
Voluntary Action Indicated (VAI)
Apr 8, 2016
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 25, 2009
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.142(a). Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
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
Morrisville, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.