FDA Inspection 819750 — I. L. Bevill Company, Inc.
The FDA completed an inspection of I. L. Bevill Company, Inc. on Feb 25, 2013 in Hoover, AL. 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). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 25, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hoover, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |