University Rx Specialties Inc.
Form 483 issued October 27, 2017 · San Diego, California
- Inspection
- Oct 17 – Oct 27, 2017
- Investigators
- Rumany C. Penn· Santiago Gallardo Johnson· Theresa Kirkham
- Observations
- 1
- Pages
- 2
- FEI number
- 3004599113
In short: On October 27, 2017, FDA issued a Form 483 with 1 observation to University Rx Specialties Inc. in San Diego, California (FEI 3004599113) after an inspection that ran Oct 17 – Oct 27, 2017. The investigators were Rumany C. Penn, Santiago Gallardo Johnson and Theresa Kirkham. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-depyrogenated equipment was used…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmUniversity Rx Specialties Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University Rx Specialties Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected University Rx Specialties Inc.?
Rumany C. Penn, Santiago Gallardo Johnson and Theresa Kirkham are named on this Form 483, for the inspection of Oct 17 – Oct 27, 2017. Each investigator has a profile showing what they cite most.
When was University Rx Specialties Inc. inspected by FDA?
The inspection ran Oct 17 – Oct 27, 2017, and the Form 483 is dated October 27, 2017.
How do I get the full Form 483 for University Rx Specialties 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.