BioScrip Pharmacy (NY), Inc.
Form 483 issued September 19, 2014 · Lake Success, New York
- Inspection
- Sep 10 – Sep 19, 2014
- Investigator
- James A. Liubicich
- Observations
- 9
- Pages
- 6
- FEI number
- 3011022663
In short: On September 19, 2014, FDA issued a Form 483 with 9 observations to BioScrip Pharmacy (NY), Inc. in Lake Success, New York (FEI 3011022663) after an inspection that ran Sep 10 – Sep 19, 2014. The investigator was James A. Liubicich. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.42 (4×)
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 maintaining any equipment used to…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmBioScrip Pharmacy (NY), Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioScrip Pharmacy (NY), Inc.?
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 BioScrip Pharmacy (NY), Inc.?
James A. Liubicich is named on this Form 483, for the inspection of Sep 10 – Sep 19, 2014. Each investigator has a profile showing what they cite most.
When was BioScrip Pharmacy (NY), Inc. inspected by FDA?
The inspection ran Sep 10 – Sep 19, 2014, and the Form 483 is dated September 19, 2014.
How do I get the full Form 483 for BioScrip Pharmacy (NY), Inc.?
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.