Stokes Pharmacy
Form 483 issued October 25, 2023 · Mount Laurel, New Jersey
- Inspection
- Sep 26 – Oct 25, 2023
- Investigators
- Christina K. Theodorou· Ruben C. Quintana· Yoriann M. Cabrera Bartolomei
- Observations
- 10
- Pages
- 11
- FEI number
- 3002815949
In short: On October 25, 2023, FDA issued a Form 483 with 10 observations to Stokes Pharmacy in Mount Laurel, New Jersey (FEI 3002815949) after an inspection that ran Sep 26 – Oct 25, 2023. The investigators were Christina K. Theodorou, Ruben C. Quintana and Yoriann M. Cabrera Bartolomei. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stokes Pharmacy?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Stokes Pharmacy?
Christina K. Theodorou, Ruben C. Quintana and Yoriann M. Cabrera Bartolomei are named on this Form 483, for the inspection of Sep 26 – Oct 25, 2023. Each investigator has a profile showing what they cite most.
When was Stokes Pharmacy inspected by FDA?
The inspection ran Sep 26 – Oct 25, 2023, and the Form 483 is dated October 25, 2023.
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.