Sina LLC, dba OncoMed (Onco 360)
Form 483 issued August 22, 2014 · Great Neck, New York
- Inspection
- Aug 7 – Aug 22, 2014
- Investigators
- Helen B. Ricalde· Robert C. Steyert
- Observations
- 9
- Pages
- 5
In short: On August 22, 2014, FDA issued a Form 483 with 9 observations to Sina LLC, dba OncoMed (Onco 360) in Great Neck, New York after an inspection that ran Aug 7 – Aug 22, 2014. The investigators were Helen B. Ricalde and Robert C. Steyert. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 8 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
· Aseptic processing areas are deficient regarding systems for mRin~in ing any equip ment used to…
- 03
Aseptic p:rocessing areas are deficient regarding the system…
- 04
Prug products purporting to be sterile and pyrogen-free are not laboratory tested to detennine…
- 05
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSina LLC, dba OncoMed (Onco 360) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sina LLC, dba OncoMed (Onco 360)?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sina LLC, dba OncoMed (Onco 360)?
Helen B. Ricalde and Robert C. Steyert are named on this Form 483, for the inspection of Aug 7 – Aug 22, 2014. Each investigator has a profile showing what they cite most.
When was Sina LLC, dba OncoMed (Onco 360) inspected by FDA?
The inspection ran Aug 7 – Aug 22, 2014, and the Form 483 is dated August 22, 2014.
How do I get the full Form 483 for Sina LLC, dba OncoMed (Onco 360)?
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.