Form 483

Steri-Pharma, LLC Form 483, 2017-03-24

FDA issued a Form 483 to Steri-Pharma, LLC on 2017-03-24 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Steri-Pharma, LLC · Syracuse, United States · Issued March 24, 2017

Overview

  • 2 public-safe observations are 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.

24 Mar 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Juan R Jimenez Garcia

24 Mar 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Juan R Jimenez Garcia

Inspected site

SLSteri-Pharma, LLCSyracuse, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

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