Thrifty White Drug #762
Form 483 issued September 21, 2018 · Minne a polis, Minnesota
- Inspection
- Sep 10 – Sep 21, 2018
- Investigators
- Anthony Ladner· Ross J. Grigsby
- Observations
- 6
- Pages
- 4
- FEI number
- 3014124016
In short: On September 21, 2018, FDA issued a Form 483 with 6 observations to Thrifty White Drug #762 in Minne a polis, Minnesota (FEI 3014124016) after an inspection that ran Sep 10 – Sep 21, 2018. The investigators were Anthony Ladner and Ross J. Grigsby. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 2 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (4×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5…
- 02FDCA 501(a)(2)(A)
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03FDCA 501(a)(2)(A)
Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to…
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 firmThrifty White Drug #762 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thrifty White Drug #762?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Thrifty White Drug #762?
Anthony Ladner and Ross J. Grigsby are named on this Form 483, for the inspection of Sep 10 – Sep 21, 2018. Each investigator has a profile showing what they cite most.
When was Thrifty White Drug #762 inspected by FDA?
The inspection ran Sep 10 – Sep 21, 2018, and the Form 483 is dated September 21, 2018.
How do I get the full Form 483 for Thrifty White Drug #762?
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.