FDA Inspection 1143403 — Tris Pharma Inc.
The FDA completed an inspection of Tris Pharma Inc. on Jun 8, 2021 in Monmouth Junction, NJ. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monmouth Junction, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |