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FDA Inspection
•Anika Therapeutics, Inc.•September 21, 2017

Anika Therapeutics, Inc. – FDA Inspection, Sep 21, 2017

Record Details

This FDA Inspection record concerns Anika Therapeutics, Inc., with an inspection on September 21, 2017, issued by the Center for Veterinary Medicine, covering veterinary.

Company
Anika Therapeutics, Inc.
Inspection Date
September 21, 2017
Product Type
Veterinary
Office
Center for Veterinary Medicine
People
  • Erik W. Koester (FDA Associated Person)
  • John P. Mistler (FDA Associated Person)
View Company Profile

ID · f33cc1a0-ae30-4873-942a-dd3d329192b6

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1025975
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
  2. 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
  3. 21 CFR 211.84(c)(4)Composite sample top/middle/bottom
  4. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  5. 21 CFR 211.192Investigations of discrepancies, failures
  6. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Anika Therapeutics, Inc.

10
DateClassificationOfficeProject area
April 13, 2026Not classifiedNew England District Office
January 22, 2026Not classifiedNew England District OfficeMonitoring of Marketed Animal Drugs, Feeds, and Devices
August 9, 2023VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
May 22, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
December 19, 2014VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
View all 10 other inspections on the company page
Other documents for Anika Therapeutics, Inc.
  • FDA Inspection 1305600 - 2026-04-13
  • FDA Inspection 1281778 - 2026-01-22
  • FDA Inspection 1214830 - 2023-08-09
  • FDA Inspection 934403 - 2015-05-22
  • FDA Inspection 906074 - 2014-12-19

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