FDA Inspection 1193146 — Louisville APL Diagnostics, Inc.
The FDA completed an inspection of Louisville APL Diagnostics, Inc. on December 19, 2022 in Texas City, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 19, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Texas City, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |