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Form 483

Onco Lab Inc. Form 483, 2010-06-16

FDA issued a Form 483 to Onco Lab Inc. on 2010-06-16 with 1 public-safe observation.

483· Form 483 issued1 observation

Onco Lab Inc. · Boston, United States · Issued June 16, 2010

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.

16 Jun 2010
21 CFR 820.20(b)(3)

Management representative

Cited by Philip H Lafleur

Inspected site

OLOnco Lab Inc.Boston, United States

Inspection team

PHPhilip H Lafleur

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

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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