Atlas

Form 483

Xtra Life Natural Products Form 483, 2019-09-30

FDA issued a Form 483 to Xtra Life Natural Products on 2019-09-30 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Xtra Life Natural Products · Hialeah, United States · Issued September 30, 2019

Overview

  • 4 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.

30 Sep 2019
21 CFR 111.70(b)(1)

Specifications - component identity

Cited by John J Bernal

30 Sep 2019
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by John J Bernal

30 Sep 2019
21 CFR 111.70(b)(1)

Specifications - component identity

Cited by John J Bernal

30 Sep 2019
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by John J Bernal

Inspected site

XLXtra Life Natural ProductsHialeah, United States

Inspection team

JJJohn J Bernal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.75(c)Cited across public-safe Form 483 observations2x

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