FDA Inspection 1086635 — Apex Pharmaceuticals Inc.
The FDA completed an inspection of Apex Pharmaceuticals Inc. on April 18, 2019 in South Plainfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |