Agilent Technologies, Inc.
Form 483 issued July 6, 2015 · Santa Clara, California
- Inspection
- Jun 2 – Jul 6, 2015
- Investigator
- Mark E. Chan
- Observations
- 2
- Pages
- 3
- FEI number
- 2916205
In short: On July 6, 2015, FDA issued a Form 483 with 2 observations to Agilent Technologies, Inc. in Santa Clara, California (FEI 2916205) after an inspection that ran Jun 2 – Jul 6, 2015. The investigator was Mark E. Chan. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.198(a) (1×) · 820.120 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures to control labeling activities have…
This inspection in context
Mark E. Chan
2 documents · 2015
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in California.
The firmAgilent Technologies, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Agilent Technologies, Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Agilent Technologies, Inc.?
Mark E. Chan is named on this Form 483, for the inspection of Jun 2 – Jul 6, 2015. Each investigator has a profile showing what they cite most.
When was Agilent Technologies, Inc. inspected by FDA?
The inspection ran Jun 2 – Jul 6, 2015, and the Form 483 is dated July 6, 2015.
How do I get the full Form 483 for Agilent Technologies, 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.