PhotoMedex, Inc.
Form 483 issued June 16, 2015 · Carlsbad, California
- Inspection
- May 27 – Jun 16, 2015
- Investigators
- Scott K. Zika· Shaquenta Y. Perkins
- Observations
- 6
- Pages
- 6
- FEI number
- 3002942014
In short: On June 16, 2015, FDA issued a Form 483 with 6 observations to PhotoMedex, Inc. in Carlsbad, California (FEI 3002942014) after an inspection that ran May 27 – Jun 16, 2015. The investigators were Scott K. Zika and Shaquenta Y. Perkins. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
CAPA and design controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
An MDRreport was not submitted within 30 days of receiving or otherwise becoming aware ofinformation that…
- 02
An MDR report was not submitted within 3 0 days of receiving or otherwise becoming aware…
- 03
Risk analysis is…
- 04
Procedures for design change have…
This inspection in context
Scott K. Zika
7 documents · 2009–2018
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmPhotoMedex, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhotoMedex, Inc.?
FDA listed 6 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected PhotoMedex, Inc.?
Scott K. Zika and Shaquenta Y. Perkins are named on this Form 483, for the inspection of May 27 – Jun 16, 2015. Each investigator has a profile showing what they cite most.
When was PhotoMedex, Inc. inspected by FDA?
The inspection ran May 27 – Jun 16, 2015, and the Form 483 is dated June 16, 2015.
How do I get the full Form 483 for PhotoMedex, 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.