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Form 483

International Sterilization Laboratory, LLC Form 483, 2019-10-10

FDA issued a Form 483 to International Sterilization Laboratory, LLC on 2019-10-10 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

International Sterilization Laboratory, LLC · Groveland, United States · Issued October 10, 2019

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.

10 Oct 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Richard K Vogel

Inspected site

ISInternational Sterilization Laboratory, LLCGroveland, United States

Inspection team

RKRichard K Vogel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF and 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