Dermazone Solutions, Inc
Form 483 issued December 6, 2022 · Saint Petersburg, Florida
- Inspection
- Nov 21 – Dec 6, 2022
- Investigator
- Kayla V. Sprague
- Observations
- 3
- Pages
- 4
- FEI number
- 1000113908
In short: On December 6, 2022, FDA issued a Form 483 with 3 observations to Dermazone Solutions, Inc in Saint Petersburg, Florida (FEI 1000113908) after an inspection that ran Nov 21 – Dec 6, 2022. The investigator was Kayla V. Sprague. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Verification of the suitability of the testing methods is deficient in that they are not performed…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dermazone Solutions, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Dermazone Solutions, Inc?
Kayla V. Sprague is named on this Form 483, for the inspection of Nov 21 – Dec 6, 2022. Each investigator has a profile showing what they cite most.
When was Dermazone Solutions, Inc inspected by FDA?
The inspection ran Nov 21 – Dec 6, 2022, and the Form 483 is dated December 6, 2022.
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.