Region Care Inc. (Northwell Health)
Form 483 issued April 5, 2006 · Great Neck, New York
- Inspection
- Apr 5, 2006
- Investigators
- Robert C. Horan· Robert C. Steyert
- Observations
- 7
- Pages
- 4
- FEI number
- 3005287250
In short: On April 5, 2006, FDA issued a Form 483 with 7 observations to Region Care Inc. (Northwell Health) in Great Neck, New York (FEI 3005287250) after an inspection that ran Apr 5, 2006. The investigators were Robert C. Horan and Robert C. Steyert. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
ings used in the manufacturing and processing of a drug product are not maintained in a…
- 04
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) 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 211.192
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 7 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Region Care Inc. (Northwell Health)?
Robert C. Horan and Robert C. Steyert are named on this Form 483, for the inspection of Apr 5, 2006. Each investigator has a profile showing what they cite most.
When was Region Care Inc. (Northwell Health) inspected by FDA?
The inspection ran Apr 5, 2006, and the Form 483 is dated April 5, 2006.
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.