Form 483

Dulces La Molienda Corp. Form 483, 2021-05-06

FDA issued a Form 483 to Dulces La Molienda Corp. on 2021-05-06 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Dulces La Molienda Corp. · San Antonio, United States · Issued May 6, 2021

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

6 May 2021
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Marc G Bellaire

6 May 2021
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Marc G Bellaire

6 May 2021
21 CFR 1.505(b)

Supplier approval - document

Cited by Marc G Bellaire

6 May 2021
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by Marc G Bellaire

Inspected site

DLDulces La Molienda Corp.San Antonio, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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