W & C dba The Apothecary
Form 483 issued July 30, 2018 · Sartell, Minnesota
- Inspection
- Jul 23 – Jul 30, 2018
- Investigator
- Charles L. Zhou
- Observations
- 1
- Pages
- 2
- FEI number
- 3012360920
In short: On July 30, 2018, FDA issued a Form 483 with 1 observation to W & C dba The Apothecary in Sartell, Minnesota (FEI 3012360920) after an inspection that ran Jul 23 – Jul 30, 2018. The investigator was Charles L. Zhou. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Y ou produced beta-lactam drugs and highly potent drugs without providing adequate cleaning ofwork surfaces and…
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 firmW & C dba The Apothecary history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at W & C dba The Apothecary?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected W & C dba The Apothecary?
Charles L. Zhou is named on this Form 483, for the inspection of Jul 23 – Jul 30, 2018. Each investigator has a profile showing what they cite most.
When was W & C dba The Apothecary inspected by FDA?
The inspection ran Jul 23 – Jul 30, 2018, and the Form 483 is dated July 30, 2018.
How do I get the full Form 483 for W & C dba The Apothecary?
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.