FDA Inspection
Appco Pharma LLCAppco Pharma LLC – FDA Inspection, May 14, 2026
Record Details
This FDA Inspection record concerns Appco Pharma LLC, with an inspection on May 14, 2026, issued by the New Jersey District Office, covering human drugs.
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ID · 70fc121e-d60a-4e25-8d7e-ed5942f9a4f0
Inspection Facts
- Inspection number
- 1301504
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- FDCA 582(b)(4)Systems in place to comply with verification requirements
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Other FDA inspections of Appco Pharma LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2024 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| August 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Appco Pharma LLC
- FDA Inspection 1232512 - 2024-03-11
- FDA Inspection 1216223 - 2023-08-29
- FDA Inspection 1179037 - 2022-08-19
- FDA Inspection 1122406 - 2020-03-27
- FDA Inspection 1093238 - 2019-05-28
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