Boothwyn Pharmacy LLC
Form 483 issued June 16, 2017 · Kennett Square, Pennsylvania
- Inspection
- Jun 5 – Jun 16, 2017
- Investigator
- Mindy M. Chou
- Observations
- 10
- Pages
- 4
- FEI number
- 1000076625
In short: On June 16, 2017, FDA issued a Form 483 with 10 observations to Boothwyn Pharmacy LLC in Kennett Square, Pennsylvania (FEI 1000076625) after an inspection that ran Jun 5 – Jun 16, 2017. The investigator was Mindy M. Chou. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 10 observations.
Most cited: 21 CFR 211.113 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Cleaning pads or wipes used in the ISO 5 aseptic processing…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
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 10 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 Boothwyn Pharmacy LLC?
Mindy M. Chou is named on this Form 483, for the inspection of Jun 5 – Jun 16, 2017. Each investigator has a profile showing what they cite most.
When was Boothwyn Pharmacy LLC inspected by FDA?
The inspection ran Jun 5 – Jun 16, 2017, and the Form 483 is dated June 16, 2017.
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.