Boothwyn Pharmacy LLC
Form 483 issued October 22, 2024 · Kennett Square, Pennsylvania
- Inspection
- Sep 23 – Oct 22, 2024
- Investigators
- Christina K. Theodorou· Juanita P. Versace· Julia N. Alvarez
- Observations
- 5
- Pages
- 12
- FEI number
- 1000076625
In short: On October 22, 2024, FDA issued a Form 483 with 5 observations to Boothwyn Pharmacy LLC in Kennett Square, Pennsylvania (FEI 1000076625) after an inspection that ran Sep 23 – Oct 22, 2024. The investigators were Christina K. Theodorou, Juanita P. Versace, Julia N. Alvarez and Rahi D. Patel. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Observation 3: scanned text, readable in the full document.
- 04
The quality control unit lacks the responsibility and authority to approve all…
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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boothwyn Pharmacy LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Boothwyn Pharmacy LLC?
Christina K. Theodorou, Juanita P. Versace, Julia N. Alvarez and Rahi D. Patel are named on this Form 483, for the inspection of Sep 23 – Oct 22, 2024. Each investigator has a profile showing what they cite most.
When was Boothwyn Pharmacy LLC inspected by FDA?
The inspection ran Sep 23 – Oct 22, 2024, and the Form 483 is dated October 22, 2024.
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.