Boothwyn Pharmacy LLC
Form 483 issued June 9, 2025 · Kennett Square, Pennsylvania
- Inspection
- May 12 – Jun 9, 2025
- Investigators
- Christina K. Theodorou· Evan Tong
- Observations
- 6
- Pages
- 6
- FEI number
- 1000076625
In short: On June 9, 2025, FDA issued a Form 483 with 6 observations to Boothwyn Pharmacy LLC in Kennett Square, Pennsylvania (FEI 1000076625) after an inspection that ran May 12 – Jun 9, 2025. The investigators were Christina K. Theodorou and Evan Tong. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and production account for 4 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
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Drug held under environmental conditions whereby it may have been…
- 03
Sterile drugs and materials were exposed to lower than…
- 04
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5…
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.
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 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Boothwyn Pharmacy LLC?
Christina K. Theodorou and Evan Tong are named on this Form 483, for the inspection of May 12 – Jun 9, 2025. Each investigator has a profile showing what they cite most.
When was Boothwyn Pharmacy LLC inspected by FDA?
The inspection ran May 12 – Jun 9, 2025, and the Form 483 is dated June 9, 2025.
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.