768845
Pharma Nobis LLC — FEI 1611206
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 16, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Texarkana, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4576 | 21 CFR 211.192 | No written record of investigation |