FDA Inspection 1171216 — Encompass Pharmaceutical Services Inc.
The FDA completed an inspection of Encompass Pharmaceutical Services Inc. on Jun 3, 2022 in Sandy Springs, GA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sandy Springs, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |