FDA Inspection 827033 — Agbanga Karite LLC
The FDA completed an inspection of Agbanga Karite LLC on Apr 24, 2013 in Tumwater, WA. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 24, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tumwater, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |