FDA Inspection 981581 — Microbiological Testing & Consulting, LLC
The FDA completed an inspection of Microbiological Testing & Consulting, LLC on July 27, 2016 in Alsip, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alsip, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |