Affymetrix, Inc

FDA inspection history in Santa Clara, California, 2015

1
Form 483

Every document, by year

  • Form 483

2015: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One Form 483, at Santa Clara, California.

Cited most

Across all Affymetrix observations on file

The complete Affymetrix file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2015-07-29483 Form 483$99

Investigators on these documents

Mary R. Hole (1)

FEI number 3003314809 · most recent document Jul 29, 2015

About Affymetrix, Inc

How many FDA Form 483s has Affymetrix, Inc received?

FDA Intel has 1 Form 483 on file for Affymetrix, Inc; the most recent is dated Jul 29, 2015.

When was Affymetrix, Inc last inspected by FDA?

The most recent FDA inspection document on file for Affymetrix, Inc is a Form 483 dated Jul 29, 2015, for the site in Santa Clara, California.

What did FDA cite at Affymetrix, Inc?

The regulations cited most in the observations on file for Affymetrix, Inc are 21 CFR 1002.10 (Product reports), 1 time; 21 CFR 806.20(b)(4) (Records of corrections and removals not required to be reported), 1 time.