Form 483

Dona Chai LLC Form 483, 2021-10-26

FDA issued a Form 483 to Dona Chai LLC on 2021-10-26 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Dona Chai LLC · Brooklyn, United States · Issued October 26, 2021

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

26 Oct 2021
21 CFR 108.25(c)(1)

Registration

Cited by Jane Chen, Morgan J Matthews

26 Oct 2021
21 CFR 108.25(c)(2)

Process filing

Cited by Jane Chen, Morgan J Matthews

26 Oct 2021
21 CFR 114.80(b)

Code - required elements

Cited by Jane Chen, Morgan J Matthews

26 Oct 2021
21 CFR 117.20(b)

Plant construction and design

Cited by Jane Chen, Morgan J Matthews

26 Oct 2021
21 CFR 117.40(f)

Instruments and Controls

Cited by Jane Chen, Morgan J Matthews

Inspected site

DCDona Chai LLCBrooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.40(f)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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