Sincerus Florida LLC
Form 483 issued September 17, 2018 · Pompano Beach, Virginia
- Inspection
- Aug 30 – Sep 17, 2018
- Investigators
- Jennifer L. Huntington· June P. Page
- Observations
- 6
- Pages
- 4
- FEI number
- 3012384835
In short: On September 17, 2018, FDA issued a Form 483 with 6 observations to Sincerus Florida LLC in Pompano Beach, Virginia (FEI 3012384835) after an inspection that ran Aug 30 – Sep 17, 2018. The investigators were Jennifer L. Huntington and June P. Page. Most observations concern laboratory controls and materials.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The in process control procedures were deficient in that they did not include an examination of…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
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 211.84(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sincerus Florida LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and production. The opening words of each observation are shown on this page.
Who inspected Sincerus Florida LLC?
Jennifer L. Huntington and June P. Page are named on this Form 483, for the inspection of Aug 30 – Sep 17, 2018. Each investigator has a profile showing what they cite most.
When was Sincerus Florida LLC inspected by FDA?
The inspection ran Aug 30 – Sep 17, 2018, and the Form 483 is dated September 17, 2018.
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.