Philips North America LLC
Form 483 issued December 3, 2018 · Bothell, Washington
- Inspection
- Oct 1 – Dec 3, 2018
- Investigators
- Paul M. Kawamoto· Phillip M. Pontikos
- Observations
- 4
- Pages
- 5
- FEI number
- 1000524572
In short: On December 3, 2018, FDA issued a Form 483 with 4 observations to Philips North America LLC in Bothell, Washington (FEI 1000524572) after an inspection that ran Oct 1 – Dec 3, 2018. The investigators were Paul M. Kawamoto and Phillip M. Pontikos. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 0421 CFR 820
Consent Decree For Permanent Injunction. Case 1:17-cv-l 1955-DJC, filed 10/31/17, required under Paragraph 8 for your…
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 firmPhilips North America LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Philips North America LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Philips North America LLC?
Paul M. Kawamoto and Phillip M. Pontikos are named on this Form 483, for the inspection of Oct 1 – Dec 3, 2018. Each investigator has a profile showing what they cite most.
When was Philips North America LLC inspected by FDA?
The inspection ran Oct 1 – Dec 3, 2018, and the Form 483 is dated December 3, 2018.
How do I get the full Form 483 for Philips North America LLC?
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.