Anika Therapeutics Inc.
Form 483 issued September 21, 2017 · Bedford, Massachusetts
- Inspection
- Sep 7 – Sep 21, 2017
- Investigators
- Erik W. Koester· John P. Mistler
- Observations
- 6
- Pages
- 6
- FEI number
- 3007093114
In short: On September 21, 2017, FDA issued a Form 483 with 6 observations to Anika Therapeutics Inc. in Bedford, Massachusetts (FEI 3007093114) after an inspection that ran Sep 7 – Sep 21, 2017. The investigators were Erik W. Koester and John P. Mistler. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Anika Therapeutics Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Anika Therapeutics Inc.?
Erik W. Koester and John P. Mistler are named on this Form 483, for the inspection of Sep 7 – Sep 21, 2017. Each investigator has a profile showing what they cite most.
When was Anika Therapeutics Inc. inspected by FDA?
The inspection ran Sep 7 – Sep 21, 2017, and the Form 483 is dated September 21, 2017.
How do I get the full Form 483 for Anika Therapeutics Inc.?
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