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Form 483

Oregon Health & Science University Form 483, 2016-01-28

FDA issued a Form 483 to Oregon Health & Science University on 2016-01-28 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

Oregon Health & Science University · Portland, United States · Issued January 28, 2016

Overview

  • 4 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.

28 Jan 2016
21 CFR 606.100(b)(15)

Schedules and procedures for equipment & calibration

Cited by Kathryn A Krentz

28 Jan 2016
21 CFR 606.60(a)

Equipment observed, standardized, calibrated

Cited by Kathryn A Krentz

28 Jan 2016
21 CFR 606.100(b)(15)

Schedules and procedures for equipment & calibration

Cited by Kathryn A Krentz

28 Jan 2016
21 CFR 606.60(a)

Equipment observed, standardized, calibrated

Cited by Kathryn A Krentz

Inspected site

OHOregon Health & Science UniversityPortland, United States

Inspection team

KAKathryn A Krentz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)(15)Cited across public-safe Form 483 observations2x
21 CFR 606.60(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

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