FDA Inspection 654125 — Pharma Nobis LLC
The FDA completed an inspection of Pharma Nobis LLC on Mar 26, 2010 in Texarkana, 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
- Mar 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Texarkana, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |