Affymetrix
FDA inspection history in Warrensville Heights, Ohio, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Warrensville Heights, Ohio.
Cited most
Across all Affymetrix observations on file
- 21 CFR 820.75(a)Process validation2
The complete Affymetrix file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Warrensville Heights, Ohio
One Form 483 · 2016 · 2 observations
Latest: Form 483, Apr 22, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-04-22 | 483 Form 483 | Warrensville Heights, Ohio | 2 | $99 |
Investigators on these documents
FEI number 3008715426 · most recent document Apr 22, 2016
About Affymetrix
How many FDA Form 483s has Affymetrix received?
FDA Intel has 1 Form 483 on file for Affymetrix; the most recent is dated Apr 22, 2016.
When was Affymetrix last inspected by FDA?
The most recent FDA inspection document on file for Affymetrix is a Form 483 dated Apr 22, 2016, for the site in Warrensville Heights, Ohio.
What did FDA cite at Affymetrix?
The regulations cited most in the observations on file for Affymetrix are 21 CFR 820.75(a) (Process validation), 2 times.