FDA Inspection 1010920 — Fruit Of The Earth, Inc.
The FDA completed an inspection of Fruit Of The Earth, Inc. on Apr 13, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 13, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |