Region Care Inc. (Northwell Health)
Form 483 issued June 10, 2016 · Great Neck, New York
- Inspection
- May 18 – Jun 10, 2016
- Investigator
- Robert C. Steyert
- Observations
- 8
- Pages
- 4
- FEI number
- 3005287250
In short: On June 10, 2016, FDA issued a Form 483 with 8 observations to Region Care Inc. (Northwell Health) in Great Neck, New York (FEI 3005287250) after an inspection that ran May 18 – Jun 10, 2016. The investigator was Robert C. Steyert. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.160 (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 do not include…
- 02
Drugs products purporting to be sterile and pyrogen-free are not laboratory tested to determine…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Laboratory controls do not include a determination of conformance to appropriate…
This inspection in context
Robert C. Steyert
6 documents · 2006–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmRegion Care Inc. (Northwell Health) history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Region Care Inc. (Northwell Health)?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Region Care Inc. (Northwell Health)?
Robert C. Steyert is named on this Form 483, for the inspection of May 18 – Jun 10, 2016. Each investigator has a profile showing what they cite most.
When was Region Care Inc. (Northwell Health) inspected by FDA?
The inspection ran May 18 – Jun 10, 2016, and the Form 483 is dated June 10, 2016.
How do I get the full Form 483 for Region Care Inc. (Northwell Health)?
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.