Wedgewood Village Pharmacy, Inc.
Form 483 issued February 11, 2013 · Swedesboro, New Jersey
- Inspection
- Nov 9, 2012 – Feb 11, 2013
- Investigators
- Barbara Wilirnczyk-Macri· Nicholas Violand· Thomas E. Friel
- Observations
- 11
- Pages
- 14
- FEI number
- 3001779702
In short: On February 11, 2013, FDA issued a Form 483 with 11 observations to Wedgewood Village Pharmacy, Inc. in Swedesboro, New Jersey (FEI 3001779702) after an inspection that ran Nov 9, 2012 – Feb 11, 2013. The investigators were Barbara Wilirnczyk-Macri, Nicholas Violand and Thomas E. Friel. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.167 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
During the inspection, personnel practices, gowning, and environmental conditions were observed that have the potential for…
- 02
Sterile veterinary compounds are not routinely tested for sterility and endotoxin limit, regardless of quantity produced…
- 03
Sterile human compounds are not always tested for sterility, even when…
- 04
There is a lack of assurance of sterility for compounded sterile human and veterinary drugs, including…
This inspection in context
Barbara Wilirnczyk-Macri
1 document · 2013
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wedgewood Village Pharmacy, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls 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 Wedgewood Village Pharmacy, Inc.?
Barbara Wilirnczyk-Macri, Nicholas Violand and Thomas E. Friel are named on this Form 483, for the inspection of Nov 9, 2012 – Feb 11, 2013. Each investigator has a profile showing what they cite most.
When was Wedgewood Village Pharmacy, Inc. inspected by FDA?
The inspection ran Nov 9, 2012 – Feb 11, 2013, and the Form 483 is dated February 11, 2013.
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.