Atlas

Form 483

Biochem Laboratory, Inc. Form 483, 2019-03-26

FDA issued a Form 483 to Biochem Laboratory, Inc. on 2019-03-26 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Biochem Laboratory, Inc. · Lyndhurst, United States · Issued March 26, 2019

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.

26 Mar 2019
21 CFR 211.160(b)(4)

Instruments, apparatus, et. al. not meeting specs

Cited by Saleem A Akhtar

Inspected site

BLBiochem Laboratory, Inc.Lyndhurst, United States

Inspection team

SASaleem A Akhtar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)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