The Apothecary Shoppe, LLC
Form 483 issued July 11, 2018 · Tulsa, Texas
- Inspection
- Jun 25 – Jul 11, 2018
- Investigator
- Margaret M. Annes
- Observations
- 6
- Pages
- 3
- FEI number
- 3001576820
In short: On July 11, 2018, FDA issued a Form 483 with 6 observations to The Apothecary Shoppe, LLC in Tulsa, Texas (FEI 3001576820) after an inspection that ran Jun 25 – Jul 11, 2018. The investigator was Margaret M. Annes. 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 6 of 6 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing were observed with exposed skin around the face and with their…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 04
Environmental monitoring samples were not performed to…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Apothecary Shoppe, LLC?
FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. 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 The Apothecary Shoppe, LLC?
Margaret M. Annes is named on this Form 483, for the inspection of Jun 25 – Jul 11, 2018. Each investigator has a profile showing what they cite most.
When was The Apothecary Shoppe, LLC inspected by FDA?
The inspection ran Jun 25 – Jul 11, 2018, and the Form 483 is dated July 11, 2018.
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.