FDA Inspection 934827 — Pharma Nobis LLC
The FDA completed an inspection of Pharma Nobis LLC on July 1, 2015 in Texarkana, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 1, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Texarkana, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4576 | 21 CFR 211.192 | No written record of investigation |