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Form 483

Biocon Biologics Limited Form 483, 2019-08-30

FDA issued a Form 483 to Biocon Biologics Limited on 2019-08-30 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Biocon Biologics Limited · Bengaluru, India · Issued August 30, 2019

Overview

  • 5 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.

30 Aug 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Bijoy Panicker

30 Aug 2019
21 CFR 211.186(b)(7)

Theoretical yield statement including percentages

Cited by Bijoy Panicker

30 Aug 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Bijoy Panicker

30 Aug 2019
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Bijoy Panicker

30 Aug 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Bijoy Panicker

Inspected site

BBBiocon Biologics LimitedBengaluru, India

Inspection team

BPBijoy Panicker

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.186(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

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