Drugs are Us, Inc. (dba Hopewell Pharmacy)
Form 483 issued March 21, 2013 · Hopewell, New Jersey
- Inspection
- Mar 18 – Mar 21, 2013
- Investigators
- Karen E. D' Orazio· Nicholas Violand
- Observations
- 3
- Pages
- 3
- FEI number
- 3001545640
In short: On March 21, 2013, FDA issued a Form 483 with 3 observations to Drugs are Us, Inc. (dba Hopewell Pharmacy) in Hopewell, New Jersey (FEI 3001545640) after an inspection that ran Mar 18 – Mar 21, 2013. The investigators were Karen E. D' Orazio and Nicholas Violand. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…
- 03
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
Karen E. D' Orazio
1 document · 2013
Cites 211.166(b) (stability testing) more than any other section. Most of their documents are for sites in New Jersey.
The firmDrugs are Us, Inc. (dba Hopewell Pharmacy) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Drugs are Us, Inc. (dba Hopewell Pharmacy)?
FDA listed 3 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 Drugs are Us, Inc. (dba Hopewell Pharmacy)?
Karen E. D' Orazio and Nicholas Violand are named on this Form 483, for the inspection of Mar 18 – Mar 21, 2013. Each investigator has a profile showing what they cite most.
When was Drugs are Us, Inc. (dba Hopewell Pharmacy) inspected by FDA?
The inspection ran Mar 18 – Mar 21, 2013, and the Form 483 is dated March 21, 2013.
How do I get the full Form 483 for Drugs are Us, Inc. (dba Hopewell Pharmacy)?
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.