Wedgewood Village Pharmacy, Inc.
Form 483 issued March 24, 2022 · Swe d e sbor o, New Jersey
- Inspection
- Mar 14 – Mar 24, 2022
- Investigators
- Kristina L. Conroy· Leanna M. Slarsky· Sean R. Marcsisin
- Observations
- 8
- Pages
- 11
- FEI number
- 3001779702
In short: On March 24, 2022, FDA issued a Form 483 with 8 observations to Wedgewood Village Pharmacy, Inc. in Swe d e sbor o, New Jersey (FEI 3001779702) after an inspection that ran Mar 14 – Mar 24, 2022. The investigators were Kristina L. Conroy, Leanna M. Slarsky and Sean R. Marcsisin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Observations span 2 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (6×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 02FDCA 501(a)(2)(A)
Observation 2: scanned text, readable in the full document.
- 03FDCA 501(a)(2)(A)
You had inadequate HEP A filter airflow over the area to which…
- 04FDCA 501(a)(2)(A)
Observation 4: scanned text, readable in the full document.
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmWedgewood Village Pharmacy, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wedgewood Village Pharmacy, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Wedgewood Village Pharmacy, Inc.?
Kristina L. Conroy, Leanna M. Slarsky and Sean R. Marcsisin are named on this Form 483, for the inspection of Mar 14 – Mar 24, 2022. Each investigator has a profile showing what they cite most.
When was Wedgewood Village Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 14 – Mar 24, 2022, and the Form 483 is dated March 24, 2022.
How do I get the full Form 483 for Wedgewood Village Pharmacy, Inc.?
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.