1149435
Monarch PCM, LLC — FEI 3012816585
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 20, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |