Magellan Rx Pharmacy, LLC
Form 483 issued December 22, 2016 · Astoria, New York
- Inspection
- Dec 6 – Dec 22, 2016
- Investigators
- Alice S. Tsao· Mindy M. Chou· Rachael Moliver
- Observations
- 3
- Pages
- 2
- FEI number
- 3012729025
In short: On December 22, 2016, FDA issued a Form 483 with 3 observations to Magellan Rx Pharmacy, LLC in Astoria, New York (FEI 3012729025) after an inspection that ran Dec 6 – Dec 22, 2016. The investigators were Alice S. Tsao, Mindy M. Chou and Rachael Moliver. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate aseptic practices were…
- 02
T here is an inadequate facility design and equipment use…
- 03
Your firm fails to have adequate cleaning and disinfecting practices in…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmMagellan Rx Pharmacy, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Magellan Rx Pharmacy, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Magellan Rx Pharmacy, LLC?
Alice S. Tsao, Mindy M. Chou and Rachael Moliver are named on this Form 483, for the inspection of Dec 6 – Dec 22, 2016. Each investigator has a profile showing what they cite most.
When was Magellan Rx Pharmacy, LLC inspected by FDA?
The inspection ran Dec 6 – Dec 22, 2016, and the Form 483 is dated December 22, 2016.
How do I get the full Form 483 for Magellan Rx Pharmacy, LLC?
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.