Anika Therapeutics Inc.
FDA inspection history in Bedford, Massachusetts, 2017 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Bedford, Massachusetts.
- 2017The longest 483 on file: 6 observations over 6 pages at Bedford, Massachusetts.
- 2023One Form 483, at Bedford, Massachusetts.
Cited most
Across all Anika Therapeutics observations on file
- 21 CFR 211.42(c)(10)(i)Design and construction features3
- 21 CFR 211.192Production record review2
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.180(e)(2)General requirements1
The complete Anika Therapeutics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bedford, Massachusetts
Two Form 483s · 2017 to 2023 · 10 observations
Latest: Form 483, Aug 9, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-09 | 483 Form 483 | Bedford, Massachusetts | 4 | $99 |
| 2017-09-21 | 483 Form 483 | Bedford, Massachusetts | 6 | $99 |
Investigators on these documents
FEI number 3007093114 · most recent document Aug 9, 2023
About Anika Therapeutics Inc.
How many FDA Form 483s has Anika Therapeutics Inc. received?
FDA Intel has 2 Form 483s on file for Anika Therapeutics Inc.; the most recent is dated Aug 9, 2023.
When was Anika Therapeutics Inc. last inspected by FDA?
The most recent FDA inspection document on file for Anika Therapeutics Inc. is a Form 483 dated Aug 9, 2023, for the site in Bedford, Massachusetts.
What did FDA cite at Anika Therapeutics Inc.?
The regulations cited most in the observations on file for Anika Therapeutics Inc. are 21 CFR 211.42(c)(10)(i) (Design and construction features), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.125(a) (Labeling issuance), 1 time.