D&D Pharma, LLC dba MedScript Compounding Pharmacy
Form 483 issued July 17, 2019 · Noblesville, Indiana
- Inspection
- Jul 8 – Jul 17, 2019
- Investigators
- Charles L. Zhou· Lewis K. Antwi· Michael Y. Philopoulos
- Observations
- 3
- Pages
- 2
- FEI number
- 3015147067
In short: On July 17, 2019, FDA issued a Form 483 with 3 observations to D&D Pharma, LLC dba MedScript Compounding Pharmacy in Noblesville, Indiana (FEI 3015147067) after an inspection that ran Jul 8 – Jul 17, 2019. The investigators were Charles L. Zhou, Lewis K. Antwi and Michael Y. Philopoulos. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not make adequate product evaluation and take remedial action where a<:tionable microbial contamination was…
- 02
-~------ (15) (4) ....... -------- testing…
- 03
Materials or supplies were not disinfected prior to entering…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmD&D Pharma, LLC dba MedScript Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at D&D Pharma, LLC dba MedScript Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected D&D Pharma, LLC dba MedScript Compounding Pharmacy?
Charles L. Zhou, Lewis K. Antwi and Michael Y. Philopoulos are named on this Form 483, for the inspection of Jul 8 – Jul 17, 2019. Each investigator has a profile showing what they cite most.
When was D&D Pharma, LLC dba MedScript Compounding Pharmacy inspected by FDA?
The inspection ran Jul 8 – Jul 17, 2019, and the Form 483 is dated July 17, 2019.
How do I get the full Form 483 for D&D Pharma, LLC dba MedScript 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.