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Form 483

Amgen Manufacturing Limited LLC Form 483, 2010-10-01

FDA issued a Form 483 to Amgen Manufacturing Limited LLC on 2010-10-01 with 2 public-safe observations.

483· Form 483 issued2 observations

Amgen Manufacturing Limited LLC · Juncos, United States · Issued October 1, 2010

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.

1 Oct 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jose E Melendez

1 Oct 2010
21 CFR 606.171

Biological product deviation report

Cited by Jose E Melendez

Inspected site

AMAmgen Manufacturing Limited LLCJuncos, United States

Inspection team

JEJose E Melendez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited 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 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