FDA Intel

Bear-Ent, LLC

FDA inspection history in Malvern, Pennsylvania, 2026

1
Form 483

Every document, by year

  • Form 483

2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2026One Form 483, at Malvern, Pennsylvania.

Cited most

Across all Bear-Ent observations on file

  • ISO 13485:2016 Clause 5.6.1
    1
  • ISO 13485:2016 Clause 6.3
    1
  • ISO 13485:2016 Clause 7.1
    Scope
    1
  • ISO 13485:2016 Clause 7.4.1
    1
  • ISO 13485:2016 Clause 7.5.6
    1

The complete Bear-Ent file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2026-02-26483 Form 483$99

Investigators on these documents

Edward D. McDonald (1)

FEI number 3021680161 · most recent document Feb 26, 2026

About Bear-Ent, LLC

How many FDA Form 483s has Bear-Ent, LLC received?

FDA Intel has 1 Form 483 on file for Bear-Ent, LLC; the most recent is dated Feb 26, 2026.

When was Bear-Ent, LLC last inspected by FDA?

The most recent FDA inspection document on file for Bear-Ent, LLC is a Form 483 dated Feb 26, 2026, for the site in Malvern, Pennsylvania.

What did FDA cite at Bear-Ent, LLC?

The regulations cited most in the observations on file for Bear-Ent, LLC are ISO 13485:2016 Clause 5.6.1, 1 time; ISO 13485:2016 Clause 6.3, 1 time; ISO 13485:2016 Clause 7.1 (Scope), 1 time.