Cerovene hie
Form 483 issued March 23, 2026 · Valley Cottage, New York
- Inspection
- Mar 16 – Mar 23, 2026
- Investigators
- Josh Renzo N. Ramilo· Yvins Dezan
- Observations
- 3
- Pages
- 5
- FEI number
- 3005890568
In short: On March 23, 2026, FDA issued a Form 483 with 3 observations to Cerovene hie in Valley Cottage, New York (FEI 3005890568) after an inspection that ran Mar 16 – Mar 23, 2026. The investigators were Josh Renzo N. Ramilo and Yvins Dezan. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Repeat) Equipment and utensils are not cleaned, maintained at appropriate intervals to prevent malfunctions contamination that…
- 02
(Repeat) Appropriate controls are not exercised over computers or related systems to assure that changes in…
- 03
Established lab control mechanisms…
This inspection in context
Josh Renzo N. Ramilo
6 documents · 2023–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmCerovene hie history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cerovene hie?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Cerovene hie?
Josh Renzo N. Ramilo and Yvins Dezan are named on this Form 483, for the inspection of Mar 16 – Mar 23, 2026. Each investigator has a profile showing what they cite most.
When was Cerovene hie inspected by FDA?
The inspection ran Mar 16 – Mar 23, 2026, and the Form 483 is dated March 23, 2026.
How do I get the full Form 483 for Cerovene hie?
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.