Form 483

Watson Pharma Private Ltd. Form 483, 2019-08-23

FDA issued a Form 483 to Watson Pharma Private Ltd. on 2019-08-23 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Watson Pharma Private Ltd. · Navi Mumbai, India · Issued August 23, 2019

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.

23 Aug 2019
21 CFR 312.60

FD-1572, protocol compliance

Cited by Janete F Guardia

Inspected site

WPWatson Pharma Private Ltd.Navi Mumbai, India

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited 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