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Form 483

Marlinz Pharma, LLC Form 483, 2022-05-04

FDA issued a Form 483 to Marlinz Pharma, LLC on 2022-05-04 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Marlinz Pharma, LLC · Houston, United States · Issued May 4, 2022

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.

4 May 2022
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Shatina R Alridge

4 May 2022
21 CFR 211.198(b)(1)

Complaint Record required information

Cited by Shatina R Alridge

Inspected site

MPMarlinz Pharma, LLCHouston, United States

Inspection team

SRShatina R Alridge

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(1)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

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