Derma Care Research Laboratories, LLC
Form 483 issued September 24, 2019 · Daytona Beach, Florida
- Inspection
- Sep 9 – Sep 24, 2019
- Investigator
- Saundrea A. Munroe
- Observations
- 1
- Pages
- 6
- FEI number
- 3013570706
In short: On September 24, 2019, FDA issued a Form 483 with 1 observation to Derma Care Research Laboratories, LLC in Daytona Beach, Florida (FEI 3013570706) after an inspection that ran Sep 9 – Sep 24, 2019. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established quality control…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmDerma Care Research Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Derma Care Research Laboratories, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Derma Care Research Laboratories, LLC?
Saundrea A. Munroe is named on this Form 483, for the inspection of Sep 9 – Sep 24, 2019. Each investigator has a profile showing what they cite most.
When was Derma Care Research Laboratories, LLC inspected by FDA?
The inspection ran Sep 9 – Sep 24, 2019, and the Form 483 is dated September 24, 2019.
How do I get the full Form 483 for Derma Care Research Laboratories, LLC?
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.