FDA Inspection 811630 — Old 97 Company
The FDA completed an inspection of Old 97 Company on Dec 27, 2012 in Tampa, FL. 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
- Dec 27, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |