Form 483

Marroko Valley Llc Form 483, 2022-09-02

FDA issued a Form 483 to Marroko Valley Llc on 2022-09-02 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Marroko Valley Llc · Mcallen, United States · Issued September 2, 2022

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.

2 Sep 2022
21 CFR 1.502(a)

Develop FSVP

Cited by Xavier M Rios

2 Sep 2022
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Xavier M Rios

2 Sep 2022
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Xavier M Rios

2 Sep 2022
21 CFR 1.506(d)(1)(i)

Verification activity frequency

Cited by Xavier M Rios

Inspected site

MVMarroko Valley LlcMcallen, United States

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 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)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