Atlas

Form 483

Watson Pharma Private Limited Form 483, 2020-01-23

FDA issued a Form 483 to Watson Pharma Private Limited on 2020-01-23 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Watson Pharma Private Limited · Verna, India · Issued January 23, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

23 Jan 2020
21 CFR 211.170(b)

Reserve samples identified, representative, stored

Cited by Arsen Karapetyan

23 Jan 2020
21 CFR 211.192

Written record of investigation incomplete

Cited by Arsen Karapetyan

23 Jan 2020
21 CFR 211.194(a)

Complete test data included in records

Cited by Arsen Karapetyan

23 Jan 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Arsen Karapetyan

Inspected site

WPWatson Pharma Private LimitedVerna, India

Inspection team

AKArsen Karapetyan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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