Diversified Pharmacy Inc dba University Compounding Pharmacy

Form 483 issued November 13, 2014 · Troy, Michigan

Inspection: Oct 29 – Nov 13, 2014
Investigators: Emily J. Orban· Sarah M. Napier
Observations: 9
Pages: 4
FEI number: 3011130315

In short: On November 13, 2014, FDA issued a Form 483 with 9 observations to Diversified Pharmacy Inc dba University Compounding Pharmacy in Troy, Michigan (FEI 3011130315) after an inspection that ran Oct 29 – Nov 13, 2014. The investigators were Emily J. Orban and Sarah M. Napier. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment3

Production2

Laboratory controls2

Materials1

Other1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be…
02
21 CFR 211.28(a)
Clothing of personnel engaged in the processing of drug products is not appropriate for…
03
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…

5 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Emily J. Orban

19 documents · 2012–2020

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.

The firm

Diversified Pharmacy Inc dba University Compounding Pharmacy history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Dec 2, 2014$199

Diversified Pharmacy Inc dba University Compounding Pharmacy site file

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Questions about this 483

What did FDA find at Diversified Pharmacy Inc dba University Compounding Pharmacy?

FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Diversified Pharmacy Inc dba University Compounding Pharmacy?

Emily J. Orban and Sarah M. Napier are named on this Form 483, for the inspection of Oct 29 – Nov 13, 2014. Each investigator has a profile showing what they cite most.

When was Diversified Pharmacy Inc dba University Compounding Pharmacy inspected by FDA?

The inspection ran Oct 29 – Nov 13, 2014, and the Form 483 is dated November 13, 2014.

How do I get the full Form 483 for Diversified Pharmacy Inc dba University Compounding 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.