Form 483

Mexilink, Inc Form 483, 2023-01-25

FDA issued a Form 483 to Mexilink, Inc on 2023-01-25 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Mexilink, Inc · Houston, United States · Issued January 25, 2023

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.

25 Jan 2023
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Brenda C Hamilton

25 Jan 2023
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Brenda C Hamilton

25 Jan 2023
21 CFR 1.505(b)

Supplier approval - document

Cited by Brenda C Hamilton

25 Jan 2023
21 CFR 1.510(b)(1)

Record - available

Cited by Brenda C Hamilton

Inspected site

MIMexilink, IncHouston, 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 1.510(b)(1)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