Buderer Drug Company
FDA inspection history across 2 sites, 2019
- 1
- Response
- 1
- Form 483
Every document, by year
- Response
- Form 483
2019: one 483 response and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One 483 response and one Form 483, at Ohio and Avon, Ohio.
Cited most
Across all Buderer Drug observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Buderer Drug file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ohio
One 483 response · 2019
Latest: Response, Mar 15, 2019 →Avon, Ohio
One Form 483 · 2019 · 1 observation
Latest: Form 483, Feb 14, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-15 | Response 483 response | Ohio | — | $199 |
| 2019-02-14 | 483 Form 483 | Avon, Ohio | 1 | $99 |
Investigators on these documents
FEI number 3011838368 · most recent document Mar 15, 2019
About Buderer Drug Company
How many FDA Form 483s has Buderer Drug Company received?
FDA Intel has 1 Form 483 on file for Buderer Drug Company; the most recent is dated Feb 14, 2019.
When was Buderer Drug Company last inspected by FDA?
The most recent FDA inspection document on file for Buderer Drug Company is a Form 483 dated Feb 14, 2019, for the site in Avon, Ohio.
What did FDA cite at Buderer Drug Company?
The regulations cited most in the observations on file for Buderer Drug Company are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.