Form 483

Pragma Pharmaceuticals Llc Form 483, 2015-03-26

FDA issued a Form 483 to Pragma Pharmaceuticals Llc on 2015-03-26 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Pragma Pharmaceuticals Llc · Locust Valley, United States · Issued March 26, 2015

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.

26 Mar 2015
21 CFR 310.305(a)

Failure to develop written procedures

Cited by Sony Mathews

Inspected site

PPPragma Pharmaceuticals LlcLocust Valley, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 310.305(a)Cited across public-safe Form 483 observations1x

Full 483 report

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Every observation in full, 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