Form 483

Sea Win, Inc. Form 483, 2021-05-04

FDA issued a Form 483 to Sea Win, Inc. on 2021-05-04 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Sea Win, Inc. · Los Angeles, United States · Issued May 4, 2021

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

4 May 2021
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Alexandra B Pitkin

4 May 2021
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Alexandra B Pitkin

4 May 2021
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Alexandra B Pitkin

Inspected site

SWSea Win, Inc.Los Angeles, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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