Sincerus Florida LLC
Form 483 issued May 29, 2026 · Pompano Beach, Florida
- Inspection
- May 18 – May 29, 2026
- Investigator
- Annet R. Rajan
- Observations
- 7
- Pages
- 7
- FEI number
- 3012384835
In short: On May 29, 2026, FDA issued a Form 483 with 7 observations to Sincerus Florida LLC in Pompano Beach, Florida (FEI 3012384835) after an inspection that ran May 18 – May 29, 2026. The investigator was Annet R. Rajan. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
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 sterile did not include…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sincerus Florida LLC?
Annet R. Rajan is named on this Form 483, for the inspection of May 18 – May 29, 2026. Each investigator has a profile showing what they cite most.
When was Sincerus Florida LLC inspected by FDA?
The inspection ran May 18 – May 29, 2026, and the Form 483 is dated May 29, 2026.
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.