Stokes Pharmacy
Form 483 issued February 12, 2016 · Mount Laurel, New Jersey
- Inspection
- Jan 27 – Feb 12, 2016
- Investigator
- Russell J. Haffion
- Observations
- 4
- Pages
- 2
- FEI number
- 3002815949
In short: On February 12, 2016, FDA issued a Form 483 with 4 observations to Stokes Pharmacy in Mount Laurel, New Jersey (FEI 3002815949) after an inspection that ran Jan 27 – Feb 12, 2016. The investigator was Russell J. Haffion. Most observations concern facilities & equipment and materials.
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prPv¢.Dt ~iliarliitlati~iroi mhf.up~·ar~ ~fl,ci~t regarqing oper~tioris related to aseptic processing of…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products· not of appropriate design…
- 03
Written procedures are not fo.llowe~ for the identification, hand~ in&…
- 04
Written procedures describing the; handling of all written.and. oral complaints do not include provisions for .review…
This inspection in context
Russell J. Haffion
1 document · 2016
Cites 211.198(a) (complaint files) more than any other section. Most of their documents are for sites in New Jersey.
The firmStokes Pharmacy history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stokes Pharmacy?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected Stokes Pharmacy?
Russell J. Haffion is named on this Form 483, for the inspection of Jan 27 – Feb 12, 2016. Each investigator has a profile showing what they cite most.
When was Stokes Pharmacy inspected by FDA?
The inspection ran Jan 27 – Feb 12, 2016, and the Form 483 is dated February 12, 2016.
How do I get the full Form 483 for Stokes 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.