FDA Inspection 1310538 — MPP PHARMA LLC
The FDA completed an inspection of MPP PHARMA LLC on Apr 2, 2026 in Kansas City, MO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 2, 2026
- Fiscal Year
- 2026
- 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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 23281 | FDCA 582(g)(1) | Establishing Enhanced Systems |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |