Stryker Corporation
Form 483 issued September 18, 2015 · San Jose, California
- Inspection
- Sep 14 – Sep 18, 2015
- Investigator
- Ashley A. Mutawakkil
- Observations
- 2
- Pages
- 3
- FEI number
- 2936485
In short: On September 18, 2015, FDA issued a Form 483 with 2 observations to Stryker Corporation in San Jose, California (FEI 2936485) after an inspection that ran Sep 14 – Sep 18, 2015. The investigator was Ashley A. Mutawakkil. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and design controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100(a) (1×) · 820.30(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design change have…
This inspection in context
Ashley A. Mutawakkil
4 documents · 2015–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Kansas.
The firmStryker Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stryker Corporation?
FDA listed 2 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Stryker Corporation?
Ashley A. Mutawakkil is named on this Form 483, for the inspection of Sep 14 – Sep 18, 2015. Each investigator has a profile showing what they cite most.
When was Stryker Corporation inspected by FDA?
The inspection ran Sep 14 – Sep 18, 2015, and the Form 483 is dated September 18, 2015.
How do I get the full Form 483 for Stryker Corporation?
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.