FDA Inspection 1025749 — ALK-Abello, Inc.
The FDA completed an inspection of ALK-Abello, Inc. on Sep 19, 2017 in Plainville, CT. 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
- Sep 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Plainville, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |