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Form 483

PAI Holdings LLC Form 483, 2023-08-02

FDA issued a Form 483 to PAI Holdings LLC on 2023-08-02 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

PAI Holdings LLC · Greenville, United States · Issued August 2, 2023

Overview

  • 2 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.

2 Aug 2023
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Sonya M Edmonds

2 Aug 2023
21 CFR 211.67(b)

Written procedures fail to include

Cited by Sonya M Edmonds

Inspected site

PHPAI Holdings LLCGreenville, United States

Inspection team

SMSonya M Edmonds

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 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