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Form 483

Dabur India Limited Form 483, 2019-12-06

FDA issued a Form 483 to Dabur India Limited on 2019-12-06 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Dabur India Limited · Dadra And Nagar Haveli, India · Issued December 6, 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.

6 Dec 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Truong X Nguyen

6 Dec 2019
21 CFR 211.68(b)

Computer control of master formula records

Cited by Truong X Nguyen

Inspected site

DIDabur India LimitedDadra And Nagar Haveli, India

Inspection team

TXTruong X Nguyen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)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