Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy
Form 483 issued September 27, 2019 · Roselle, Illinois
- Inspection
- Sep 16 – Sep 27, 2019
- Investigators
- Anthony Ladner· Norman K. Starks
- Observations
- 4
- Pages
- 2
- FEI number
- 3004486825
In short: On September 27, 2019, FDA issued a Form 483 with 4 observations to Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy in Roselle, Illinois (FEI 3004486825) after an inspection that ran Sep 16 – Sep 27, 2019. The investigators were Anthony Ladner and Norman K. Starks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
ISO 5 classified areas were not…
- 02
Wipes used in the ISO 5 aseptic processing…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
You have no assurance that the endotoxin level of your intrathecal drug products are safe, since…
This inspection in context
Anthony Ladner
10 documents · 2016–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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
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 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy?
Anthony Ladner and Norman K. Starks are named on this Form 483, for the inspection of Sep 16 – Sep 27, 2019. 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 Sep 16 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
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.