FDA Inspection 671018 — Penniman & Browne, Inc.
The FDA completed an inspection of Penniman & Browne, Inc. on Jul 9, 2010 in Baltimore, MD. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |