FDA Inspection 1012564 — Louisville APL Diagnostics, Inc.
The FDA completed an inspection of Louisville APL Diagnostics, Inc. on June 2, 2017 in Texas City, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Texas City, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |