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Form 483

Zydus Hospira Oncology Private Limited Form 483, 2019-10-22

FDA issued a Form 483 to Zydus Hospira Oncology Private Limited on 2019-10-22 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Zydus Hospira Oncology Private Limited · Matoda, India · Issued October 22, 2019

Overview

  • 3 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.

22 Oct 2019
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Junho Pak

22 Oct 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Junho Pak

22 Oct 2019
21 CFR 211.42(c)(10)(vi)

Equipment to control conditions

Cited by Junho Pak

Inspected site

ZHZydus Hospira Oncology Private LimitedMatoda, India

Inspection team

JPJunho Pak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x

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 3 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