FDA Inspection 1314716 — Boehringer Laboratories, Inc.
The FDA completed an inspection of Boehringer Laboratories, Inc. on Jun 24, 2026 in Phoenixville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Phoenixville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |