CorneaGen - Boston
Form 483 issued December 20, 2024 · Waltham
- Inspection
- Dec 10 – Dec 20, 2024
- Investigator
- Anthony N. Onianwa
- Observations
- 2
- Pages
- 4
- FEI number
- 1000513310
In short: On December 20, 2024, FDA issued a Form 483 with 2 observations to CorneaGen - Boston in Waltham (FEI 1000513310) after an inspection that ran Dec 10 – Dec 20, 2024. The investigator was Anthony N. Onianwa.
What FDA observed
Preview: the opening words of each observation- 01
Donors were not determined to be ineligible that had risk factors or clinical evidence…
- 02
HCT/Ps that were recovered from a donor for whom a donor eligibility determination has not been…
This inspection in context
Anthony N. Onianwa
2 documents · 2010–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Connecticut.
The firmCorneaGen - Boston history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at CorneaGen - Boston?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected CorneaGen - Boston?
Anthony N. Onianwa is named on this Form 483, for the inspection of Dec 10 – Dec 20, 2024. Each investigator has a profile showing what they cite most.
When was CorneaGen - Boston inspected by FDA?
The inspection ran Dec 10 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
How do I get the full Form 483 for CorneaGen - Boston?
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.