Sincerus Florida LLC
Form 483 issued March 6, 2025 · Pompano Beach, Florida
- Inspection
- Feb 13 – Mar 6, 2025
- Investigator
- Jennifer Lalama
- Observations
- 3
- Pages
- 4
- FEI number
- 3012384835
In short: On March 6, 2025, FDA issued a Form 483 with 3 observations to Sincerus Florida LLC in Pompano Beach, Florida (FEI 3012384835) after an inspection that ran Feb 13 – Mar 6, 2025. The investigator was Jennifer Lalama. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02FDCA 501(a)(2)(A)
Hazardous chugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 03FDCA 503B(a)(10)(B)
Observation 3: scanned text, readable in the full document.
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmSincerus Florida LLC history
All 8 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 Sincerus Florida LLC?
FDA listed 3 observations on this Form 483, mostly about quality system. 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 Sincerus Florida LLC?
Jennifer Lalama is named on this Form 483, for the inspection of Feb 13 – Mar 6, 2025. Each investigator has a profile showing what they cite most.
When was Sincerus Florida LLC inspected by FDA?
The inspection ran Feb 13 – Mar 6, 2025, and the Form 483 is dated March 6, 2025.
How do I get the full Form 483 for Sincerus Florida 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.