FDA Inspection 1113094 — Eagle Analytical Services, Inc.
The FDA completed an inspection of Eagle Analytical Services, Inc. on December 17, 2019 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |