Form 483

Natra US Inc Form 483, 2021-09-24

FDA issued a Form 483 to Natra US Inc on 2021-09-24 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Natra US Inc · San Diego, United States · Issued September 24, 2021

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

24 Sep 2021
21 CFR 1.504(a)

Hazard analysis written

Cited by Lisa M Schultz

24 Sep 2021
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Lisa M Schultz

24 Sep 2021
21 CFR 1.505(b)

Supplier approval - document

Cited by Lisa M Schultz

Inspected site

NUNatra US IncSan Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x

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