Dermazone Solutions, Inc
Form 483 issued April 11, 2019 · Saint Petersburg, Florida
- Inspection
- Apr 8 – Apr 11, 2019
- Investigator
- Stanley B. Eugene
- Observations
- 4
- Pages
- 4
- FEI number
- 1000113908
In short: On April 11, 2019, FDA issued a Form 483 with 4 observations to Dermazone Solutions, Inc in Saint Petersburg, Florida (FEI 1000113908) after an inspection that ran Apr 8 – Apr 11, 2019. The investigator was Stanley B. Eugene. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
3 of 4 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for changes to a specification, method and process have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
- 03
Calibration procedures do not include…
- 04
Personnel training is not…
This inspection in context
Stanley B. Eugene
6 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmDermazone Solutions, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dermazone Solutions, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Dermazone Solutions, Inc?
Stanley B. Eugene is named on this Form 483, for the inspection of Apr 8 – Apr 11, 2019. Each investigator has a profile showing what they cite most.
When was Dermazone Solutions, Inc inspected by FDA?
The inspection ran Apr 8 – Apr 11, 2019, and the Form 483 is dated April 11, 2019.
How do I get the full Form 483 for Dermazone Solutions, 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.