FDA Inspection 1304536 - Bear-Ent, Llc - February 26, 2026

Record Details

This FDA Inspection record concerns Bear-Ent, Llc, with an inspection on February 26, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.

Company: Bear-Ent, Llc
Inspection Date: February 26, 2026
Product Type: Medical Devices & Rad Health
Office: Philadelphia District Office

Open in Dashboard

ID · dbe31a8a-414d-43c5-bb1f-de75fd75377f

Violation Codes7

ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 6.3ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.2.4

Full citation text and observation details available on the Dashboard.