Anika Therapeutics Inc.
Form 483 issued August 9, 2023 · Bedford, Massachusetts
- Inspection
- Jul 24 – Aug 9, 2023
- Investigator
- Erik W. Koester
- Observations
- 4
- Pages
- 10
- FEI number
- 3007093114
In short: On August 9, 2023, FDA issued a Form 483 with 4 observations to Anika Therapeutics Inc. in Bedford, Massachusetts (FEI 3007093114) after an inspection that ran Jul 24 – Aug 9, 2023. The investigator was Erik W. Koester. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
There's a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAnika Therapeutics Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Anika Therapeutics Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Anika Therapeutics Inc.?
Erik W. Koester is named on this Form 483, for the inspection of Jul 24 – Aug 9, 2023. Each investigator has a profile showing what they cite most.
When was Anika Therapeutics Inc. inspected by FDA?
The inspection ran Jul 24 – Aug 9, 2023, and the Form 483 is dated August 9, 2023.
How do I get the full Form 483 for Anika Therapeutics Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.