University Rx Specialties Inc.
Form 483 issued September 21, 2015 · San Diego, California
- Inspection
- Aug 13 – Sep 21, 2015
- Investigator
- Linda Thai
- Observations
- 7
- Pages
- 6
- FEI number
- 3004599113
In short: On September 21, 2015, FDA issued a Form 483 with 7 observations to University Rx Specialties Inc. in San Diego, California (FEI 3004599113) after an inspection that ran Aug 13 – Sep 21, 2015. The investigator was Linda Thai. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Linda Thai
18 documents · 2014–2025
Cites 211.192 (production record review) 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 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University Rx Specialties Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 University Rx Specialties Inc.?
Linda Thai is named on this Form 483, for the inspection of Aug 13 – Sep 21, 2015. Each investigator has a profile showing what they cite most.
When was University Rx Specialties Inc. inspected by FDA?
The inspection ran Aug 13 – Sep 21, 2015, and the Form 483 is dated September 21, 2015.
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.