Oregon Compounding Centers, Inc.
FDA inspection history in Wilsonville, Oregon, 2014
- 2
- Form 483s
- 1
- Response
Every document, by year
- Response
- Form 483
2014: one 483 response, one amended 483 and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One 483 response, one amended 483 and one Form 483, at Wilsonville, Oregon.
- 2014The longest 483 on file: 10 observations over 11 pages at Wilsonville, Oregon.
Cited most
Across all Oregon Compounding Centers observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features6
- 21 CFR 211.113(b)Control of microbiological contamination4
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166(b)Stability testing2
- 21 CFR 211.167(a)Special testing requirements2
The complete Oregon Compounding Centers 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
Wilsonville, Oregon
One 483 response, one amended 483 and one Form 483 · 2014 · 20 observations
Latest: Response, Oct 1, 2014 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-10-01 | Response 483 response | Wilsonville, Oregon | — | $199 |
| 2014-09-12 | Amended 483 Amended 483 | Wilsonville, Oregon | 10 | $99 |
| 2014-08-28 | 483 Form 483 | Wilsonville, Oregon | 10 | $99 |
Investigators on these documents
Anita Narula (3)Heika R. Tait (3)Eileen A. Liu (2)Jamie M. Du (2)
FEI number 3005580627 · most recent document Oct 1, 2014
About Oregon Compounding Centers, Inc.
How many FDA Form 483s has Oregon Compounding Centers, Inc. received?
FDA Intel has 2 Form 483s on file for Oregon Compounding Centers, Inc.; the most recent is dated Sep 12, 2014.
When was Oregon Compounding Centers, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Oregon Compounding Centers, Inc. is a Form 483 dated Sep 12, 2014, for the site in Wilsonville, Oregon.
What did FDA cite at Oregon Compounding Centers, Inc.?
The regulations cited most in the observations on file for Oregon Compounding Centers, Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 6 times; 21 CFR 211.113(b) (Control of microbiological contamination), 4 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times.