FDA Inspection 638769 — King Pharmaceuticals LLC
The FDA completed an inspection of King Pharmaceuticals LLC on January 19, 2010 in Rochester, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rochester, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |