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Form 483

Amneal Oncology Private Limited Form 483, 2019-10-25

FDA issued a Form 483 to Amneal Oncology Private Limited on 2019-10-25 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Amneal Oncology Private Limited · Hyderabad, India · Issued October 25, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

25 Oct 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Felix Maldonado

Inspected site

AOAmneal Oncology Private LimitedHyderabad, India

Inspection team

FMFelix Maldonado

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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