Form 483

Nutritional Laboratories International Inc Form 483, 2013-12-13

FDA issued a Form 483 to Nutritional Laboratories International Inc on 2013-12-13 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Nutritional Laboratories International Inc · Missoula, United States · Issued December 13, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

13 Dec 2013
21 CFR 211.84(d)(6)

Microbiological Contamination Exam

Cited by Maria P Kelly-Doggett

13 Dec 2013
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Maria P Kelly-Doggett

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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