FDA Inspection 571229 — Medaus, Inc.
The FDA completed an inspection of Medaus, Inc. on February 12, 2009 in Hoover, AL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 12, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hoover, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1870 | 21 CFR 211.94(d) | Written Procedures to Remove Pyrogens |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |