Form 483

Nutraceutic Labs Inc Form 483, 2022-07-20

FDA issued a Form 483 to Nutraceutic Labs Inc on 2022-07-20 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Nutraceutic Labs Inc · Miami, United States · Issued July 20, 2022

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

20 Jul 2022
21 CFR 111.103

Written procedures - quality control operations

Cited by Marinee Flores-Marrero

20 Jul 2022
21 CFR 111.12(b)

Personnel - quality control operations

Cited by Marinee Flores-Marrero

20 Jul 2022
21 CFR 111.255(b)

Batch record - complete

Cited by Marinee Flores-Marrero

20 Jul 2022
21 CFR 111.27(b)

Instruments - calibration

Cited by Marinee Flores-Marrero

20 Jul 2022
21 CFR 111.55

Production, process controls - implement

Cited by Marinee Flores-Marrero

Inspected site

NLNutraceutic Labs IncMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.12(b)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.27(b)Cited across public-safe Form 483 observations1x
21 CFR 111.55Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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