Sincerus Florida LLC
Form 483 issued June 26, 2020 · Pompano Beach, Florida
- Inspection
- Jun 26, 2020
- Investigator
- Bonita S. Chester
- Observations
- 3
- Pages
- 2
- FEI number
- 3012384835
In short: On June 26, 2020, FDA issued a Form 483 with 3 observations to Sincerus Florida LLC in Pompano Beach, Florida (FEI 3012384835) after an inspection that ran Jun 26, 2020. The investigator was Bonita S. Chester. Most observations concern packaging & labeling and production.
At a glance
2 of 3 observations on this 483 concern packaging & labeling.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to assme that coITect labeling and packaging materials are used for chug products are…
- 03
The labels of your outsourcing facility's…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
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 211.113
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 packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected Sincerus Florida LLC?
Bonita S. Chester is named on this Form 483, for the inspection of Jun 26, 2020. Each investigator has a profile showing what they cite most.
When was Sincerus Florida LLC inspected by FDA?
The inspection ran Jun 26, 2020, and the Form 483 is dated June 26, 2020.
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.