Form 483

AMPHENOL ALDEN PRODUCTS COMPANY Form 483, 2024-01-18

FDA issued a Form 483 to AMPHENOL ALDEN PRODUCTS COMPANY on 2024-01-18 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

AMPHENOL ALDEN PRODUCTS COMPANY · Severiano Talamante No. 6-B, Mexico · Issued January 18, 2024

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

18 Jan 2024
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Daniel R Tammariello, Michelle L Johnson

Inspected site

AAAMPHENOL ALDEN PRODUCTS COMPANYSeveriano Talamante No. 6-B, Mexico

Inspection team

MLMichelle L Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x

Full 483 report

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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