Bear-Ent, LLC
Form 483 issued February 26, 2026 · Malvern, Pennsylvania
- Inspection
- Feb 18 – Feb 26, 2026
- Investigator
- Edward D. McDonald
- Observations
- 7
- Pages
- 5
- FEI number
- 3021680161
In short: On February 26, 2026, FDA issued a Form 483 with 7 observations to Bear-Ent, LLC in Malvern, Pennsylvania (FEI 3021680161) after an inspection that ran Feb 18 – Feb 26, 2026. The investigator was Edward D. McDonald.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
Records of risk management activities in product…
- 02ISO 13485:2016 Clause 8.2.2
Complaint handling records were…
- 03ISO 13485:2016 Clause 7.5.6
Records of the results and conclusion of validation of processes and necessary actions from the…
- 04ISO 13485:2016 Clause 6.3
Requirements for infrastructure maintenance activities that can affect product quality, including the interval of performing the…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBear-Ent, LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Bear-Ent, LLC?
FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Bear-Ent, LLC?
Edward D. McDonald is named on this Form 483, for the inspection of Feb 18 – Feb 26, 2026. Each investigator has a profile showing what they cite most.
When was Bear-Ent, LLC inspected by FDA?
The inspection ran Feb 18 – Feb 26, 2026, and the Form 483 is dated February 26, 2026.
How do I get the full Form 483 for Bear-Ent, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.