FDA Inspection 1041092 — Lex, Inc.
The FDA completed an inspection of Lex, Inc. on February 14, 2018 in Medley, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2398 | 21 CFR 211.194(a)(2) | Test methods ID and data location |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4576 | 21 CFR 211.192 | No written record of investigation |