W & C dba The Apothecary
Form 483 issued June 17, 2016 · Sartell, Minnesota
- Inspection
- Jun 6 – Jun 17, 2016
- Investigators
- Anthony Ladner· Gregory A. Berg· James K. Ireland
- Observations
- 7
- Pages
- 4
- FEI number
- 3012360920
In short: On June 17, 2016, FDA issued a Form 483 with 7 observations to W & C dba The Apothecary in Sartell, Minnesota (FEI 3012360920) after an inspection that ran Jun 6 – Jun 17, 2016. The investigators were Anthony Ladner, Gregory A. Berg and James K. Ireland. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
There is no written testing program designed to assess the stability…
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 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 211.42(c)(10)(iv)
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 7 observations on this Form 483, mostly about laboratory controls, 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 W & C dba The Apothecary?
Anthony Ladner, Gregory A. Berg and James K. Ireland are named on this Form 483, for the inspection of Jun 6 – Jun 17, 2016. Each investigator has a profile showing what they cite most.
When was W & C dba The Apothecary inspected by FDA?
The inspection ran Jun 6 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
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.