Atlas

Form 483

Boehringer Laboratories, Inc. Form 483, 2026-06-24

FDA issued a Form 483 to Boehringer Laboratories, Inc. on 2026-06-24 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Boehringer Laboratories, Inc. · Phoenixville, United States · Issued June 24, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

24 Jun 2026
ISO 13485:2016 Clause 7.3.10

Design and development files not maintained

Cited by Nadia R Barreda

24 Jun 2026
ISO 13485:2016 Clause 7.5.6

Procedures for validation of processes not documented

Cited by Nadia R Barreda

Inspected site

BLBoehringer Laboratories, Inc.Phoenixville, United States

Inspection team

NRNadia R Barreda

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.3.10Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere