FDA Inspection 664407 — Med Resources, Inc.
The FDA completed an inspection of Med Resources, Inc. on Jun 1, 2010 in Chesterfield, MO. 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chesterfield, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |