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Form 483

KEDPlasma, LLC Form 483, 2022-11-10

FDA issued a Form 483 to KEDPlasma, LLC on 2022-11-10 with 6 public-safe observations.

483· Form 483 issuedBiologics6 observations

KEDPlasma, LLC · Pensacola, United States · Issued November 10, 2022

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

10 Nov 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Nisha C Patel

10 Nov 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Nisha C Patel

10 Nov 2022
21 CFR 606.100(c)

Thorough investigations

Cited by Nisha C Patel

10 Nov 2022
21 CFR 606.100(c)

Thorough investigations

Cited by Nisha C Patel

10 Nov 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Nisha C Patel

Inspected site

KLKEDPlasma, LLCPensacola, United States

Inspection team

NCNisha C Patel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations3x
21 CFR 606.100(c)Cited across public-safe Form 483 observations3x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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