Form 483

We Make Vitamins LLC Form 483, 2015-06-29

FDA issued a Form 483 to We Make Vitamins LLC on 2015-06-29 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

We Make Vitamins LLC · Lakeland, United States · Issued June 29, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

29 Jun 2015
21 CFR 111.255(b)

Batch record - complete

Cited by Jennifer A Robinson

29 Jun 2015
21 CFR 111.325(a)

Written procedures, laboratory operations

Cited by Jennifer A Robinson

29 Jun 2015
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Jennifer A Robinson

29 Jun 2015
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Jennifer A Robinson

Inspected site

WMWe Make Vitamins LLCLakeland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.325(a)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

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