FDA Inspection 1070966 — The Methodist Hospital Research Institute
The FDA completed an inspection of The Methodist Hospital Research Institute on November 2, 2018 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17822 | 21 CFR 212.50(b)(7) | Complete instructions, procedures, specs |
| 17849 | 21 CFR 212.60(a) | Testing procedures |
| 17863 | 21 CFR 212.60(g)(3) | Complete record of all laboratory test data |
| 17898 | 21 CFR 212.71(c) | Correction of problems |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |