Form 483

Life Science Labs Manufacturing LLC Form 483, 2022-06-30

FDA issued a Form 483 to Life Science Labs Manufacturing LLC on 2022-06-30 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Life Science Labs Manufacturing LLC · Lakewood, United States · Issued June 30, 2022

Overview

  • 3 public-safe observations are 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.

30 Jun 2022
21 CFR 111.75(a)(2)(ii)(E)

Documentation - quality control, review, approve supplier

Cited by Dhaval H Patel

30 Jun 2022
21 CFR 111.75(a)(2)(ii)(E)

Documentation - quality control, review, approve supplier

Cited by Dhaval H Patel

30 Jun 2022
21 CFR 111.75(a)(2)(ii)(E)

Documentation - quality control, review, approve supplier

Cited by Dhaval H Patel

Inspected site

LSLife Science Labs Manufacturing LLCLakewood, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.75(a)(2)(ii)(E)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 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