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FDA establishment 3010014758, Piscataway, New Jersey, United States. Part of APPCO Pharma's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 9
Official action indicated: 0
Last inspection ended: May 14, 2026
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.
02018Inspections0
220192019Inspections2vs 2018+2
12020Inspections1vs 2019−1
020212021Inspections0vs 2020−1
12022Inspections1vs 2021+1
120232023Inspections1vs 2022+0
12024Inspections1vs 2023+0
020252025Inspections0vs 2024−1
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
FDCA 582(b)(4): Systems in place to comply with verification requirements1
FDCA 582(b)(4). Systems in place to comply with verification requirements Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
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.
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 211.192. 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 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Voluntary Action Indicated (VAI)
Mar 11, 2024
Drugs · Bioresearch Monitoring
2 cited references
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.
21 CFR 314.80(c)(1)(ii). Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not investigated.
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
Piscataway, New Jersey, United States. Part of