Pharmacy Creations
Form 483 issued September 30, 2015 · Randolph, New Jersey
- Inspection
- Aug 27 – Sep 30, 2015
- Investigators
- Helen Verdel· Michael R. Klapal
- Observations
- 3
- Pages
- 2
- FEI number
- 3003348498
In short: On September 30, 2015, FDA issued a Form 483 with 3 observations to Pharmacy Creations in Randolph, New Jersey (FEI 3003348498) after an inspection that ran Aug 27 – Sep 30, 2015. The investigators were Helen Verdel and Michael R. Klapal. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
An adequate number of batches of each drug product are not tested to determine…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
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 211.166(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Creations?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Pharmacy Creations?
Helen Verdel and Michael R. Klapal are named on this Form 483, for the inspection of Aug 27 – Sep 30, 2015. Each investigator has a profile showing what they cite most.
When was Pharmacy Creations inspected by FDA?
The inspection ran Aug 27 – Sep 30, 2015, and the Form 483 is dated September 30, 2015.
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.