Affymetrix, Inc
Form 483 issued July 29, 2015 · Santa Clara, California
- Inspection
- Jul 21 – Jul 29, 2015
- Investigator
- Mary R. Hole
- Observations
- 2
- Pages
- 2
- FEI number
- 3003314809
In short: On July 29, 2015, FDA issued a Form 483 with 2 observations to Affymetrix, Inc in Santa Clara, California (FEI 3003314809) after an inspection that ran Jul 21 – Jul 29, 2015. The investigator was Mary R. Hole. Most observations concern cAPA; the most-cited regulation is 21 CFR 1002.10 (product reports).
At a glance
Observations span 1 system, led by capa.
Most cited: 21 CFR 1002.10 (1×) · 806.20(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not submit a required product report prior to the introduction of…
- 02
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups…
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmAffymetrix, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1002.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Affymetrix, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 1002.10 (product reports). The opening words of each observation are shown on this page.
Who inspected Affymetrix, Inc?
Mary R. Hole is named on this Form 483, for the inspection of Jul 21 – Jul 29, 2015. Each investigator has a profile showing what they cite most.
When was Affymetrix, Inc inspected by FDA?
The inspection ran Jul 21 – Jul 29, 2015, and the Form 483 is dated July 29, 2015.
How do I get the full Form 483 for Affymetrix, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.