Buderer Drug Company Inc.
FDA inspection history across 2 sites, 2016 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter and one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s and one warning letter, at Perrysburg, Ohio and Penysburg, Ohio.
- 2016The longest 483 on file: 5 observations over 2 pages at Perrysburg, Ohio.
Cited most
Across all Buderer Drug Company observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Buderer Drug Company file.
All 3 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
Perrysburg, Ohio
One warning letter and one Form 483 · 2016 · 5 observations
Latest: Warning letter, Sep 20, 2016 →Penysburg, Ohio
One Form 483 · 2017 · 3 observations
Latest: Form 483, Jul 24, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-07-24 | 483 Form 483 | Penysburg, Ohio | 3 | $99 |
| 2016-09-20 | Warning letter Warning letter | Perrysburg, Ohio | — | $99 |
| 2016-01-04 | 483 Form 483 | Perrysburg, Ohio | 5 | $99 |
Investigators on these documents
FEI number 3005664940 · most recent document Jul 24, 2017
About Buderer Drug Company Inc.
How many FDA Form 483s has Buderer Drug Company Inc. received?
FDA Intel has 2 Form 483s on file for Buderer Drug Company Inc.; the most recent is dated Jul 24, 2017.
When was Buderer Drug Company Inc. last inspected by FDA?
The most recent FDA inspection document on file for Buderer Drug Company Inc. is a Form 483 dated Jul 24, 2017, for the site in Penysburg, Ohio.
What did FDA cite at Buderer Drug Company Inc.?
The regulations cited most in the observations on file for Buderer Drug Company Inc. are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.167(a) (Special testing requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Buderer Drug Company Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Buderer Drug Company Inc.; the most recent is dated Sep 20, 2016.