Form 483

Las Dos Californias Inc DBA Dulceria los Cuates Form 483, 2023-10-19

FDA issued a Form 483 to Las Dos Californias Inc DBA Dulceria los Cuates on 2023-10-19 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Las Dos Californias Inc DBA Dulceria los Cuates · San Diego, United States · Issued October 19, 2023

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.

19 Oct 2023
21 CFR 1.502(a)

Develop FSVP

Cited by Alyson M Nicks

19 Oct 2023
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Alyson M Nicks

19 Oct 2023
21 CFR 1.506(d)(1)(ii)

Verification activity - appropriate

Cited by Alyson M Nicks

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(ii)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