Drug factory · FDA FEI 3010014758

Appco Pharma LLC

262 Old New Brunswick Rd Suite M, N, B-1, F & K, Piscataway, NJ, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 14, 2026 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

Mar 11, 2024 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.
• Failure to investigate serious, unexpected events 21 CFR 314.80(c)(1)(ii)
  Adverse drug experiences that were the subject of post marketing 15-day reports were not investigated.

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.