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Form 483

Marlex Pharmaceuticals, Inc. Form 483, 2021-08-12

FDA issued a Form 483 to Marlex Pharmaceuticals, Inc. on 2021-08-12 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Marlex Pharmaceuticals, Inc. · New Castle, United States · Issued August 12, 2021

Overview

  • 1 public-safe observation is 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.

12 Aug 2021
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Stephanie C Mangigian

Inspected site

MPMarlex Pharmaceuticals, Inc.New Castle, United States

Inspection team

SCStephanie C Mangigian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)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