Diversified Pharmacy Inc dba University Compounding Pharmacy
Form 483 issued June 19, 2017 · Troy, Michigan
- Inspection
- Jun 19, 2017
- Investigators
- Emilie Kahn· Sarah E. Rhoades
- Observations
- 3
- Pages
- 2
- FEI number
- 3011130315
In short: On June 19, 2017, FDA issued a Form 483 with 3 observations to Diversified Pharmacy Inc dba University Compounding Pharmacy in Troy, Michigan (FEI 3011130315) after an inspection that ran Jun 19, 2017. The investigators were Emilie Kahn and Sarah E. Rhoades. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO-classified areas have difficult to clean, particle-generating, or visibly dirty…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmDiversified 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 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diversified Pharmacy Inc dba University Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. 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 Diversified Pharmacy Inc dba University Compounding Pharmacy?
Emilie Kahn and Sarah E. Rhoades are named on this Form 483, for the inspection of Jun 19, 2017. 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 Jun 19, 2017, and the Form 483 is dated June 19, 2017.
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.