Atlas

Form 483

Boehringer Laboratories, Inc. Form 483, 2013-08-13

FDA issued a Form 483 to Boehringer Laboratories, Inc. on 2013-08-13 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Boehringer Laboratories, Inc. · Phoenixville, United States · Issued August 13, 2013

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

13 Aug 2013
21 CFR 820.30(g)

Design validation - documentation

Cited by Tania E Vizcaino

Inspected site

BLBoehringer Laboratories, Inc.Phoenixville, United States

Inspection team

TETania E Vizcaino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

Every observation in full, 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