Atlas

Form 483

Alter Eco Americas, Inc. Form 483, 2020-02-12

FDA issued a Form 483 to Alter Eco Americas, Inc. on 2020-02-12 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Alter Eco Americas, Inc. · San Francisco, United States · Issued February 12, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

12 Feb 2020
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Clarice J Ahn, Huy T Pham

12 Feb 2020
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Clarice J Ahn, Huy T Pham

Inspected site

AEAlter Eco Americas, Inc.San Francisco, United States

Inspection team

CJClarice J Ahn
HTHuy T Pham

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 1.506(e)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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