Atlas

Form 483

Akshar Sales LLC Form 483, 2018-09-13

FDA issued a Form 483 to Akshar Sales LLC on 2018-09-13 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Akshar Sales LLC · Fremont, United States · Issued September 13, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

13 Sep 2018
21 CFR 1.504(a)

Hazard analysis written

Cited by Melody M Ragasa Leong, Melody M Ragasa-Leong

13 Sep 2018
21 CFR 1.505(b)

Supplier approval - document

Cited by Melody M Ragasa Leong, Melody M Ragasa-Leong

Inspected site

ASAkshar Sales LLCFremont, United States

Inspection team

MMMelody M Ragasa Leong
MMMelody M Ragasa-Leong

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(b)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