Abrams Royal Pharmacy II, LLC
Form 483 issued May 11, 2015 · Plano, Texas
- Inspection
- Apr 27 – May 11, 2015
- Investigators
- Jason R. Caballero· Lisa R. Jennings
- Observations
- 3
- Pages
- 3
- FEI number
- 3011286375
In short: On May 11, 2015, FDA issued a Form 483 with 3 observations to Abrams Royal Pharmacy II, LLC in Plano, Texas (FEI 3011286375) after an inspection that ran Apr 27 – May 11, 2015. The investigators were Jason R. Caballero and Lisa R. Jennings. Most observations concern laboratory controls and production.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your flnn has not establi shed appropriate testing and release procedures and controls to ensure finis…
- 02
Your firm h as not established procedures and controls to ensure finished drug product's Beyond Use…
- 03
Your firm has not established procedures to ensure appropriate clothing is wom by your personnel engaged…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAbrams Royal Pharmacy II, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abrams Royal Pharmacy II, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Abrams Royal Pharmacy II, LLC?
Jason R. Caballero and Lisa R. Jennings are named on this Form 483, for the inspection of Apr 27 – May 11, 2015. Each investigator has a profile showing what they cite most.
When was Abrams Royal Pharmacy II, LLC inspected by FDA?
The inspection ran Apr 27 – May 11, 2015, and the Form 483 is dated May 11, 2015.
How do I get the full Form 483 for Abrams Royal Pharmacy II, 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.