FDA Inspection 1006798 — Analytical Food Laboratories Inc.
The FDA completed an inspection of Analytical Food Laboratories Inc. on Apr 7, 2017 in Grand Prairie, TX. 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
- Apr 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |