Wedgewood Village Pharmacy, Inc.

Form 483 issued September 29, 2015 · Swedesboro, New Jersey

Inspection: Aug 26 – Sep 29, 2015
Investigator: Russell J. Glapion
Observations: 6
Pages: 4
FEI number: 3001779702

In short: On September 29, 2015, FDA issued a Form 483 with 6 observations to Wedgewood Village Pharmacy, Inc. in Swedesboro, New Jersey (FEI 3001779702) after an inspection that ran Aug 26 – Sep 29, 2015. The investigator was Russell J. Glapion. Most observations concern facilities & equipment and production.

At a glance

Facilities & equipment and production account for 4 of 6 observations.

Facilities & equipment2

Production2

Laboratory controls1

Quality system1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
02
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
03
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
04
21 CFR 211.28(a)
Clothing ofpersonnel engaged in the processing and packing of drug products is not appropriate for…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Russell J. Glapion

18 documents · 2013–2021

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Wedgewood Village Pharmacy, Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.165(a)

See how FDA wrote the same problem up elsewhere.

Original PDF$99

✓ All 4 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

Response
The firm's reply to this 483Oct 20, 2015$199

Wedgewood Village Pharmacy, Inc. site file

All 6 documents for this site in one go: $590 instead of ~~$694~~, 15% off.

See the site history

Questions about this 483

What did FDA find at Wedgewood Village Pharmacy, Inc.?

FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Wedgewood Village Pharmacy, Inc.?

Russell J. Glapion is named on this Form 483, for the inspection of Aug 26 – Sep 29, 2015. Each investigator has a profile showing what they cite most.

When was Wedgewood Village Pharmacy, Inc. inspected by FDA?

The inspection ran Aug 26 – Sep 29, 2015, and the Form 483 is dated September 29, 2015.

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.