Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy
Form 483 issued November 17, 2017 · Flint, Michigan
- Inspection
- Oct 31 – Nov 17, 2017
- Investigators
- Bei Y. He· Emily J. Orban
- Observations
- 4
- Pages
- 4
- FEI number
- 3010299526
In short: On November 17, 2017, FDA issued a Form 483 with 4 observations to Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy in Flint, Michigan (FEI 3010299526) after an inspection that ran Oct 31 – Nov 17, 2017. The investigators were Bei Y. He and Emily J. Orban. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had difficult to…
- 02
Your firm released drug product in which the strength differs from, or its purity or quality…
- 03
inadequately protected product intended to be sterile was exposed to lower than ISO 5 classified aseptic…
- 04
Disinfecting agents an d cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmDiplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy history
The site's inspection history, in date order.
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 Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy?
Bei Y. He and Emily J. Orban are named on this Form 483, for the inspection of Oct 31 – Nov 17, 2017. Each investigator has a profile showing what they cite most.
When was Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy inspected by FDA?
The inspection ran Oct 31 – Nov 17, 2017, and the Form 483 is dated November 17, 2017.
How do I get the full Form 483 for Diplomat Pharmacy Inc. dba Diplomat Specialty 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.