The Apothecary Shoppe, LLC
Form 483 issued March 13, 2015 · Tulsa, Texas
- Inspection
- Mar 4 – Mar 5, 2015
- Investigators
- Lisa R. Jennings· Margaret M. Annes
- Observations
- 10
- Pages
- 6
- FEI number
- 3001576820
In short: On March 13, 2015, FDA issued a Form 483 with 10 observations to The Apothecary Shoppe, LLC in Tulsa, Texas (FEI 3001576820) after an inspection that ran Mar 4 – Mar 5, 2015. The investigators were Lisa R. Jennings and Margaret M. Annes. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 8 of 10 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Lisa R. Jennings
7 documents · 2014–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmThe Apothecary Shoppe, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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 The Apothecary Shoppe, LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 The Apothecary Shoppe, LLC?
Lisa R. Jennings and Margaret M. Annes are named on this Form 483, for the inspection of Mar 4 – Mar 5, 2015. Each investigator has a profile showing what they cite most.
When was The Apothecary Shoppe, LLC inspected by FDA?
The inspection ran Mar 4 – Mar 5, 2015, and the Form 483 is dated March 13, 2015.
How do I get the full Form 483 for The Apothecary Shoppe, LLC?
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.