Overview
- 12 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-13.
At a glance
Inspections
12
Form 483s
9
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 13 Apr 2026 | Biologics | Clean | |
| 7 Apr 2026 | Biologics | Clean | |
| 12 Jan 2026 – 22 Jan 2026 | Animal Drugs & Feeds | 483 | View 483 → |
| 24 Jul 2023 – 9 Aug 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 7 Sep 2017 – 21 Sep 2017 | Animal Drugs & Feeds | 483 | View 483 → |
| 20 May 2015 – 22 May 2015 | Medical Devices & Rad Health | Clean | |
| 2 Dec 2014 – 19 Dec 2014 | Animal Drugs & Feeds | 483 | View 483 → |
| 14 Nov 2012 | Not recorded | 483 | View 483 → |
| 31 Oct 2011 | Not recorded | 483 | View 483 → |
| 9 Dec 2010 | Not recorded | 483 | On file |
| 28 Jul 2010 | Not recorded | 483 | On file |
| 12 Mar 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jan 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Erik W Koester, Raihan A Chowdhury, Armen H Youssoufian
22 Jan 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Erik W Koester, Raihan A Chowdhury, Armen H Youssoufian
22 Jan 2026
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Erik W Koester, Raihan A Chowdhury, Armen H Youssoufian
22 Jan 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Erik W Koester, Raihan A Chowdhury, Armen H Youssoufian
Investigators
FDA investigators tied to this site in the record.
Erik W Koester3 insp.
David E Lowe2 insp.
Pratima Labroo2 insp.
John P Mistler2 insp.
Sandra P White2 insp.
Raihan A Chowdhury1 insp.
Armen H Youssoufian1 insp.
Stephen C Smith1 insp.
Stacey S Degarmo1 insp.
Jayaleka J Amarasinghe1 insp.
Maura Rooney1 insp.
Suzanne M Healy1 insp.
Jonathan G Matrisciano1 insp.
Dawn M Braswell1 insp.
Darin S Wiegers1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Anika Therapeutics, Inc.'s 9 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat