Form 483

Nephron Sterile Compounding Center, LLC Form 483, 2018-04-20

FDA issued a Form 483 to Nephron Sterile Compounding Center, LLC on 2018-04-20 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Nephron Sterile Compounding Center, LLC · West Columbia, United States · Issued April 20, 2018

Overview

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

Inspectional observations

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

20 Apr 2018
21 CFR 211.28(a)

Clothing appropriate for duties performed

Cited by Seneca D Toms, Larry K Hampton

Inspected site

NSNephron Sterile Compounding Center, LLCWest Columbia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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