FDA Inspection 675961 — United States Department Of Health & Human Services
The FDA completed an inspection of United States Department Of Health & Human Services on Aug 16, 2010 in Perry Point, 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Perry Point, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 1979 | 21 CFR 211.182 | Chronological Order of Equipment Log Entries |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |