FDA Inspection 1301504 — Appco Pharma LLC
The FDA completed an inspection of Appco Pharma LLC on May 14, 2026 in Piscataway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 14, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Piscataway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |