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Form 483

Indoco Remedies Limited Form 483, 2018-11-21

FDA issued a Form 483 to Indoco Remedies Limited on 2018-11-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Indoco Remedies Limited · Verna, India · Issued November 21, 2018

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.

21 Nov 2018
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Patric C Klotzbuecher

21 Nov 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Patric C Klotzbuecher

Inspected site

IRIndoco Remedies LimitedVerna, India

Inspection team

PCPatric C Klotzbuecher

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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