Wykle, Inc
Form 483 issued May 10, 2019 · Carson City, Nevada
- Inspection
- May 6 – May 10, 2019
- Investigator
- Paul M. Kawamoto
- Observations
- 1
- Pages
- 6
In short: On May 10, 2019, FDA issued a Form 483 with 1 observation to Wykle, Inc in Carson City, Nevada after an inspection that ran May 6 – May 10, 2019. The investigator was Paul M. Kawamoto. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Paul M. Kawamoto
7 documents · 2015–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Washington.
The firmWykle, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wykle, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Wykle, Inc?
Paul M. Kawamoto is named on this Form 483, for the inspection of May 6 – May 10, 2019. Each investigator has a profile showing what they cite most.
When was Wykle, Inc inspected by FDA?
The inspection ran May 6 – May 10, 2019, and the Form 483 is dated May 10, 2019.
How do I get the full Form 483 for Wykle, 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.