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Form 483

Indoco Remedies Limited Form 483, 2019-10-15

FDA issued a Form 483 to Indoco Remedies Limited on 2019-10-15 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Indoco Remedies Limited · Verna, India · Issued October 15, 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.

15 Oct 2019
21 CFR 211.52

Washing and toilet facilities not provided and accessible

Cited by Felix Maldonado

15 Oct 2019
21 CFR 211.68(b)

Computer control of master formula records

Cited by Felix Maldonado

Inspected site

IRIndoco Remedies LimitedVerna, India

Inspection team

FMFelix Maldonado

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.52Cited 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