Synapse Biomedical Inc
FDA inspection history in Oberlin, Ohio, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Oberlin, Ohio.
Cited most
Across all Synapse Biomedical observations on file
- 21 CFR 820.30Design controls1
- 21 CFR 820.75Process validation1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90Nonconforming product1
The complete Synapse Biomedical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Oberlin, Ohio
One Form 483 · 2020 · 4 observations
Latest: Form 483, Oct 7, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-10-07 | 483 Form 483 | Oberlin, Ohio | 4 | $99 |
Investigators on these documents
FEI number 3005868392 · most recent document Oct 7, 2020
About Synapse Biomedical Inc
How many FDA Form 483s has Synapse Biomedical Inc received?
FDA Intel has 1 Form 483 on file for Synapse Biomedical Inc; the most recent is dated Oct 7, 2020.
When was Synapse Biomedical Inc last inspected by FDA?
The most recent FDA inspection document on file for Synapse Biomedical Inc is a Form 483 dated Oct 7, 2020, for the site in Oberlin, Ohio.
What did FDA cite at Synapse Biomedical Inc?
The regulations cited most in the observations on file for Synapse Biomedical Inc are 21 CFR 820.30 (Design controls), 1 time; 21 CFR 820.75 (Process validation), 1 time; 21 CFR 820.80 (Receiving, in-process, and finished device acceptance), 1 time.