Form 483

FB Laboratories Inc. Form 483, 2022-06-15

FDA issued a Form 483 to FB Laboratories Inc. on 2022-06-15 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

FB Laboratories Inc. · Hauppauge, United States · Issued June 15, 2022

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.

15 Jun 2022
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Eric J Reisenauer, Betty M Ng-Lee

Inspected site

FLFB Laboratories Inc.Hauppauge, United States

Inspection team

BMBetty M Ng-Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x

Full 483 report

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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