Pharmacy Creations
Form 483 issued April 9, 2019 · Ledgewood, New Jersey
- Inspection
- Apr 9, 2019
- Investigators
- Jay T. Wong· Nancy F. Scheraga
- Observations
- 1
- Pages
- 1
- FEI number
- 3003348498
In short: On April 9, 2019, FDA issued a Form 483 with 1 observation to Pharmacy Creations in Ledgewood, New Jersey (FEI 3003348498) after an inspection that ran Apr 9, 2019. The investigators were Jay T. Wong and Nancy F. Scheraga. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 7 Filling Room is not adequately constructed to…
This inspection in context
Jay T. Wong
5 documents · 2019–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharmacy Creations history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Creations?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pharmacy Creations?
Jay T. Wong and Nancy F. Scheraga are named on this Form 483, for the inspection of Apr 9, 2019. Each investigator has a profile showing what they cite most.
When was Pharmacy Creations inspected by FDA?
The inspection ran Apr 9, 2019, and the Form 483 is dated April 9, 2019.
How do I get the full Form 483 for Pharmacy Creations?
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.