Boothwyn Pharmacy LLC
Form 483 issued September 8, 2021 · Kennett Square, Pennsylvania
- Inspection
- Aug 17 – Sep 8, 2021
- Investigators
- Sena G. Dissmeyer· Tanya R. Syffrard
- Observations
- 9
- Pages
- 9
- FEI number
- 1000076625
In short: On September 8, 2021, FDA issued a Form 483 with 9 observations to Boothwyn Pharmacy LLC in Kennett Square, Pennsylvania (FEI 1000076625) after an inspection that ran Aug 17 – Sep 8, 2021. The investigators were Sena G. Dissmeyer and Tanya R. Syffrard. 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 8 of 9 observations.
Most cited: 21 CFR 211.113 (5×) · 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
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 02
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…
- 03
Equipment was and Materials or supplies were not disinfected prior to entering…
- 04
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic…
This inspection in context
Sena G. Dissmeyer
20 documents · 2017–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmBoothwyn Pharmacy LLC history
All 8 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 Boothwyn Pharmacy LLC?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Boothwyn Pharmacy LLC?
Sena G. Dissmeyer and Tanya R. Syffrard are named on this Form 483, for the inspection of Aug 17 – Sep 8, 2021. Each investigator has a profile showing what they cite most.
When was Boothwyn Pharmacy LLC inspected by FDA?
The inspection ran Aug 17 – Sep 8, 2021, and the Form 483 is dated September 8, 2021.
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.