Diversified Pharmacy Inc dba University Compounding Pharmacy
FDA inspection history in Troy, Michigan, 2014 to 2018
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Warning letter
- Response
2014: one 483 response and one Form 483; 2016: one warning letter; 2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–18Two Form 483s, one 483 response, one warning letter and one close-out letter, at Troy, Michigan.
- 2014The longest 483 on file: 9 observations over 4 pages at Troy, Michigan.
Cited most
Across all Diversified Pharmacy Inc dba University Compounding Pharmacy observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Diversified Pharmacy Inc dba University Compounding Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Troy, Michigan
Two Form 483s, one close-out letter, one warning letter and one 483 response · 2014 to 2018 · 12 observations
Latest: Close-out, Sep 12, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-09-12 | Close-out Close-out letter | Troy, Michigan | — | $99 |
| 2017-06-19 | 483 Form 483 | Troy, Michigan | 3 | $99 |
| 2016-02-26 | Warning letter Warning letter | Troy, Michigan | — | $99 |
| 2014-12-02 | Response 483 response | Troy, Michigan | — | $199 |
| 2014-11-13 | 483 Form 483 | Troy, Michigan | 9 | $99 |
Investigators on these documents
Emily J. Orban (2)Sarah M. Napier (2)Emilie Kahn (1)Sarah E. Rhoades (1)
FEI number 3011130315 · most recent document Sep 12, 2018
About Diversified Pharmacy Inc dba University Compounding Pharmacy
How many FDA Form 483s has Diversified Pharmacy Inc dba University Compounding Pharmacy received?
FDA Intel has 2 Form 483s on file for Diversified Pharmacy Inc dba University Compounding Pharmacy; the most recent is dated Jun 19, 2017.
When was Diversified Pharmacy Inc dba University Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Diversified Pharmacy Inc dba University Compounding Pharmacy is a Form 483 dated Jun 19, 2017, for the site in Troy, Michigan.
What did FDA cite at Diversified Pharmacy Inc dba University Compounding Pharmacy?
The regulations cited most in the observations on file for Diversified Pharmacy Inc dba University Compounding Pharmacy are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Diversified Pharmacy Inc dba University Compounding Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Diversified Pharmacy Inc dba University Compounding Pharmacy; the most recent is dated Feb 26, 2016.