Affymetrix
Form 483 issued April 22, 2016 · Warrensville Heights, Ohio
- Inspection
- Apr 6 – Apr 22, 2016
- Investigator
- Benjamin Dastoli
- Observations
- 2
- Pages
- 2
- FEI number
- 3008715426
In short: On April 22, 2016, FDA issued a Form 483 with 2 observations to Affymetrix in Warrensville Heights, Ohio (FEI 3008715426) after an inspection that ran Apr 6 – Apr 22, 2016. The investigator was Benjamin Dastoli. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmAffymetrix history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Affymetrix?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Affymetrix?
Benjamin Dastoli is named on this Form 483, for the inspection of Apr 6 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was Affymetrix inspected by FDA?
The inspection ran Apr 6 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
How do I get the full Form 483 for Affymetrix?
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.