Stokes Pharmacy
Form 483 issued May 23, 2025 · Mount Laurel, New Jersey
- Inspection
- May 13 – May 23, 2025
- Investigator
- Taichun Qin
- Observations
- 5
- Pages
- 7
- FEI number
- 3002815949
In short: On May 23, 2025, FDA issued a Form 483 with 5 observations to Stokes Pharmacy in Mount Laurel, New Jersey (FEI 3002815949) after an inspection that ran May 13 – May 23, 2025. The investigator was Taichun Qin. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stokes Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Stokes Pharmacy?
Taichun Qin is named on this Form 483, for the inspection of May 13 – May 23, 2025. Each investigator has a profile showing what they cite most.
When was Stokes Pharmacy inspected by FDA?
The inspection ran May 13 – May 23, 2025, and the Form 483 is dated May 23, 2025.
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.