FDA Inspection 1281834 — Microbiological Testing & Consulting, LLC
The FDA completed an inspection of Microbiological Testing & Consulting, LLC on Sep 16, 2025 in Alsip, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alsip, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |