University Rx Specialties Inc.
FDA inspection history in San Diego, California, 2015 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s and one warning letter, at San Diego, California.
- 2015The longest 483 on file: 7 observations over 6 pages at San Diego, California.
Cited most
Across all University Rx Specialties observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete University Rx Specialties file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Diego, California
Two Form 483s and one warning letter · 2015 to 2017 · 8 observations
Latest: Form 483, Oct 27, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-10-27 | 483 Form 483 | San Diego, California | 1 | $99 |
| 2016-09-28 | Warning letter Warning letter | San Diego, California | — | $99 |
| 2015-09-21 | 483 Form 483 | San Diego, California | 7 | $99 |
Investigators on these documents
Linda Thai (1)Rumany C. Penn (1)Santiago Gallardo Johnson (1)Theresa Kirkham (1)
FEI number 3004599113 · most recent document Oct 27, 2017
About University Rx Specialties Inc.
How many FDA Form 483s has University Rx Specialties Inc. received?
FDA Intel has 2 Form 483s on file for University Rx Specialties Inc.; the most recent is dated Oct 27, 2017.
When was University Rx Specialties Inc. last inspected by FDA?
The most recent FDA inspection document on file for University Rx Specialties Inc. is a Form 483 dated Oct 27, 2017, for the site in San Diego, California.
What did FDA cite at University Rx Specialties Inc.?
The regulations cited most in the observations on file for University Rx Specialties Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has University Rx Specialties Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for University Rx Specialties Inc.; the most recent is dated Sep 28, 2016.