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Form 483

ZENARA PHARMA PRIVATE LIMITED Form 483, 2019-04-26

FDA issued a Form 483 to ZENARA PHARMA PRIVATE LIMITED on 2019-04-26 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

ZENARA PHARMA PRIVATE LIMITED · Hyderabad, India · Issued April 26, 2019

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.

26 Apr 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jason R Caballero

26 Apr 2019
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Jason R Caballero

Inspected site

ZPZENARA PHARMA PRIVATE LIMITEDHyderabad, India

Inspection team

JRJason R Caballero

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)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