Form 483

Ferndale Laboratories, Inc. Form 483, 2017-02-03

FDA issued a Form 483 to Ferndale Laboratories, Inc. on 2017-02-03 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Ferndale Laboratories, Inc. · Ferndale, United States · Issued February 3, 2017

Overview

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

Inspectional observations

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

3 Feb 2017
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Bei Y He, Emilie Kahn

Inspected site

FLFerndale Laboratories, Inc.Ferndale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.67(b)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