Dermazone Solutions, Inc
Form 483 issued November 24, 2015 · Saint Petersburg, Florida
- Inspection
- Oct 28 – Nov 24, 2015
- Investigator
- Michael H. Tollon
- Observations
- 9
- Pages
- 5
- FEI number
- 1000113908
In short: On November 24, 2015, FDA issued a Form 483 with 9 observations to Dermazone Solutions, Inc in Saint Petersburg, Florida (FEI 1000113908) after an inspection that ran Oct 28 – Nov 24, 2015. The investigator was Michael H. Tollon. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.194 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The suitability of all testing methods is not verified under…
- 03
There is a failure to tlioroughly review any unexplained discrepancy and the failure of a batch…
- 04
An adequate number of batches of each drug product are not tested nor are records of…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dermazone Solutions, Inc?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Dermazone Solutions, Inc?
Michael H. Tollon is named on this Form 483, for the inspection of Oct 28 – Nov 24, 2015. Each investigator has a profile showing what they cite most.
When was Dermazone Solutions, Inc inspected by FDA?
The inspection ran Oct 28 – Nov 24, 2015, and the Form 483 is dated November 24, 2015.
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.