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Form 483

Apothecon Pharmaceuticals Private Limited Form 483, 2023-06-16

FDA issued a Form 483 to Apothecon Pharmaceuticals Private Limited on 2023-06-16 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Apothecon Pharmaceuticals Private Limited · Taluka Padra, Vadodara, India · Issued June 16, 2023

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.

16 Jun 2023
21 CFR 211.111

Establishment of time limitations

Cited by Jazmine N Brown

Inspected site

APApothecon Pharmaceuticals Private LimitedTaluka Padra, Vadodara, India

Inspection team

JNJazmine N Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.111Cited 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