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Form 483

Spectrum Pharmaceuticals, Inc. Form 483, 2016-05-27

FDA issued a Form 483 to Spectrum Pharmaceuticals, Inc. on 2016-05-27 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Spectrum Pharmaceuticals, Inc. · Boston, United States · Issued May 27, 2016

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.

27 May 2016
21 CFR 312.56(b)

Investigator non-compliance

Cited by Diane C Van Leeuwen

27 May 2016
21 CFR 312.56(a)

Monitoring investigations

Cited by Diane C Van Leeuwen

Inspected site

SPSpectrum Pharmaceuticals, Inc.Boston, United States

Inspection team

DCDiane C Van Leeuwen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.56(a)Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)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 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