The Apothecary Shoppe, LLC
Form 483 issued January 18, 2022 · Tulsa, Oklahoma
- Inspection
- Jan 18, 2022
- Investigator
- Margaret M. Annes
- Observations
- 5
- Pages
- 4
- FEI number
- 3001576820
In short: On January 18, 2022, FDA issued a Form 483 with 5 observations to The Apothecary Shoppe, LLC in Tulsa, Oklahoma (FEI 3001576820) after an inspection that ran Jan 18, 2022. The investigator was Margaret M. Annes. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from that which it purports or…
- 02
Your cleanrooms are outfitted with HEPA filters directly adjacent to the return…
- 03
There is a lack of routine and rigorous certification of the ISO 5 area, including smoke…
- 04
You used a non-pharmaceutical grade component in the formulation…
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 5 observations on this Form 483, mostly about production, laboratory controls 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 Jan 18, 2022. Each investigator has a profile showing what they cite most.
When was The Apothecary Shoppe, LLC inspected by FDA?
The inspection ran Jan 18, 2022, and the Form 483 is dated January 18, 2022.
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.