Form 483

Sea Watch International, Ltd. Form 483, 2017-06-09

FDA issued a Form 483 to Sea Watch International, Ltd. on 2017-06-09 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Sea Watch International, Ltd. · Milford, United States · Issued June 9, 2017

Overview

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

Inspectional observations

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

9 Jun 2017
21 CFR 113.40(a)(2)(iii)

Adjusted to agree with TID

Cited by Mark A Jackson

Inspected site

SWSea Watch International, Ltd.Milford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.40(a)(2)(iii)Cited across public-safe Form 483 observations1x

Full 483 report

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Every observation in full, 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