PhotoMedex, Inc.
FDA inspection history in Carlsbad, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Carlsbad, California.
Cited most
Across all PhotoMedex observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.80(d)Receiving, in-process, and finished device acceptance1
The complete PhotoMedex file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Carlsbad, California
One Form 483 · 2015 · 6 observations
Latest: Form 483, Jun 16, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-06-16 | 483 Form 483 | Carlsbad, California | 6 | $99 |
Investigators on these documents
FEI number 3002942014 · most recent document Jun 16, 2015
About PhotoMedex, Inc.
How many FDA Form 483s has PhotoMedex, Inc. received?
FDA Intel has 1 Form 483 on file for PhotoMedex, Inc.; the most recent is dated Jun 16, 2015.
When was PhotoMedex, Inc. last inspected by FDA?
The most recent FDA inspection document on file for PhotoMedex, Inc. is a Form 483 dated Jun 16, 2015, for the site in Carlsbad, California.
What did FDA cite at PhotoMedex, Inc.?
The regulations cited most in the observations on file for PhotoMedex, Inc. are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.