Abrams Royal Pharmacy
Form 483 issued December 20, 2013 · Dallas, Texas
- Inspection
- Dec 12 – Dec 20, 2013
- Investigators
- Elisa M. Fleming· Scott Ballard
- Observations
- 12
- Pages
- 8
- FEI number
- 1000138425
In short: On December 20, 2013, FDA issued a Form 483 with 12 observations to Abrams Royal Pharmacy in Dallas, Texas (FEI 1000138425) after an inspection that ran Dec 12 – Dec 20, 2013. The investigators were Elisa M. Fleming and Scott Ballard. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
The quality control unit lacks authority to fully investigate…
This inspection in context
Elisa M. Fleming
3 documents · 2011–2015
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmAbrams Royal Pharmacy 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abrams Royal Pharmacy?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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 Abrams Royal Pharmacy?
Elisa M. Fleming and Scott Ballard are named on this Form 483, for the inspection of Dec 12 – Dec 20, 2013. Each investigator has a profile showing what they cite most.
When was Abrams Royal Pharmacy inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2013, and the Form 483 is dated December 20, 2013.
How do I get the full Form 483 for Abrams Royal Pharmacy?
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.