FDA Inspection 1304536 — Bear-Ent, Llc
The FDA completed an inspection of Bear-Ent, Llc on February 26, 2026 in Malvern, PA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Malvern, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23063 | ISO 13485:2016 Clause 5.6.1 | Management review records not maintained |
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |