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Form 483

Hetero Labs Limited Form 483, 2016-10-26

FDA issued a Form 483 to Hetero Labs Limited on 2016-10-26 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Hetero Labs Limited · Hyderabad, India · Issued October 26, 2016

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

26 Oct 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Pratik S Upadhyay

26 Oct 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Pratik S Upadhyay

26 Oct 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Pratik S Upadhyay

26 Oct 2016
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Pratik S Upadhyay

26 Oct 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Pratik S Upadhyay

Inspected site

HLHetero Labs LimitedHyderabad, India

Inspection team

PSPratik S Upadhyay

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 6 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