FDA Inspection 1126698 — AACE Pharmaceuticals, Inc.
The FDA completed an inspection of AACE Pharmaceuticals, Inc. on Aug 10, 2020 in Fairfield, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 10, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fairfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |