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Form 483

Anika Therapeutics, Inc. Form 483, 2012-11-14

FDA issued a Form 483 to Anika Therapeutics, Inc. on 2012-11-14 with 1 public-safe observation.

483· Form 483 issued1 observation

Anika Therapeutics, Inc. · Bedford, United States · Issued November 14, 2012

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.

14 Nov 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maura Rooney

Inspected site

ATAnika Therapeutics, Inc.Bedford, United States

Inspection team

MRMaura Rooney

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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