FDA Inspection 631758 — MPP PHARMA LLC
The FDA completed an inspection of MPP PHARMA LLC on Dec 1, 2009 in Kansas City, MO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 1, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 8913 | 21 CFR 314.81(b)(2)(iv)(a) | Reports re: chemical, physical, or other properties |