Boothwyn Pharmacy LLC
Form 483 issued August 29, 2023 · Kennett Square, Pennsylvania
- Inspection
- Aug 9 – Aug 29, 2023
- Investigator
- Christina K. Theodorou
- Observations
- 5
- Pages
- 5
- FEI number
- 1000076625
In short: On August 29, 2023, FDA issued a Form 483 with 5 observations to Boothwyn Pharmacy LLC in Kennett Square, Pennsylvania (FEI 1000076625) after an inspection that ran Aug 9 – Aug 29, 2023. The investigator was Christina K. Theodorou.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Smoke studies were inadequately…
- 02FDCA 501(a)(2)(A)
The facility design was observed to allow the influx of lesser quality air into a classified…
- 03FDCA 501(a)(2)(A)
Use of non-sterile cleaning wipes in…
- 04FDCA 501(a)(2)(A)
Use of a sporicidal agent in the facility's ISO 5 areas and…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBoothwyn Pharmacy LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Boothwyn Pharmacy LLC?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Boothwyn Pharmacy LLC?
Christina K. Theodorou is named on this Form 483, for the inspection of Aug 9 – Aug 29, 2023. Each investigator has a profile showing what they cite most.
When was Boothwyn Pharmacy LLC inspected by FDA?
The inspection ran Aug 9 – Aug 29, 2023, and the Form 483 is dated August 29, 2023.
How do I get the full Form 483 for Boothwyn Pharmacy 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.