FDA Inspection 1187509 — Engler Engineering Corp.
The FDA completed an inspection of Engler Engineering Corp. on November 8, 2022 in Hialeah, FL. 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
- November 8, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3837 | 21 CFR 820.25(b) | Training records |