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Form 483

Cyndea Pharma SL Form 483, 2019-04-12

FDA issued a Form 483 to Cyndea Pharma SL on 2019-04-12 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Cyndea Pharma SL · Olvega, Spain · Issued April 12, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

12 Apr 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Darren S Brown, Tianhong Zhou

12 Apr 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Darren S Brown, Tianhong Zhou

Inspected site

CPCyndea Pharma SLOlvega, Spain

Inspection team

DSDarren S Brown
TZTianhong Zhou

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 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

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