FDA Inspection 1032508 — Prompt Praxis Laboratories LLC
The FDA completed an inspection of Prompt Praxis Laboratories LLC on December 1, 2017 in Vernon Hills, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |