Synapse Biomedical Inc
Form 483 issued October 7, 2020 · Oberlin, Ohio
- Inspection
- Sep 15 – Oct 7, 2020
- Investigators
- Benjamin Dastoli· Laureen M. Geniusz
- Observations
- 4
- Pages
- 11
- FEI number
- 3005868392
In short: On October 7, 2020, FDA issued a Form 483 with 4 observations to Synapse Biomedical Inc in Oberlin, Ohio (FEI 3005868392) after an inspection that ran Sep 15 – Oct 7, 2020. The investigators were Benjamin Dastoli and Laureen M. Geniusz. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Risk analysis is…
- 03
Procedures have not been established to control product that does not…
- 04
Acceptance activities were not…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmSynapse Biomedical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Synapse Biomedical Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Synapse Biomedical Inc?
Benjamin Dastoli and Laureen M. Geniusz are named on this Form 483, for the inspection of Sep 15 – Oct 7, 2020. Each investigator has a profile showing what they cite most.
When was Synapse Biomedical Inc inspected by FDA?
The inspection ran Sep 15 – Oct 7, 2020, and the Form 483 is dated October 7, 2020.
How do I get the full Form 483 for Synapse Biomedical 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.