FDA Inspection 941882 — Reliant Holdings, Ltd.
The FDA completed an inspection of Reliant Holdings, Ltd. on Sep 11, 2015 in Maricopa, AZ. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maricopa, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4576 | 21 CFR 211.192 | No written record of investigation |