Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy
Form 483 issued May 22, 2017 · Roselle, Illinois
- Inspection
- Apr 26 – May 22, 2017
- Investigators
- Bryan L. McGuckin· Christopher D. Leach
- Observations
- 6
- Pages
- 4
- FEI number
- 3004486825
In short: On May 22, 2017, FDA issued a Form 483 with 6 observations to Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy in Roselle, Illinois (FEI 3004486825) after an inspection that ran Apr 26 – May 22, 2017. The investigators were Bryan L. McGuckin and Christopher D. Leach. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmSnyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy?
Bryan L. McGuckin and Christopher D. Leach are named on this Form 483, for the inspection of Apr 26 – May 22, 2017. Each investigator has a profile showing what they cite most.
When was Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy inspected by FDA?
The inspection ran Apr 26 – May 22, 2017, and the Form 483 is dated May 22, 2017.
How do I get the full Form 483 for Snyder Mark Drugs Roselle, Inc. dba Mark Drugs 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.