Form 483

Bausch & Lomb Incorporated Form 483, 2010-10-25

FDA issued a Form 483 to Bausch & Lomb Incorporated on 2010-10-25 with 1 public-safe observation.

483· Form 483 issued1 observation

Bausch & Lomb Incorporated · Tampa, United States · Issued October 25, 2010

Overview

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

Inspectional observations

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

25 Oct 2010
21 CFR 211.165(c)

Sampling and testing plans not followed

Cited by Michael H Tollon, Daryl A Dewoskin

Inspected site

B&Bausch & Lomb IncorporatedTampa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(c)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