Stokes Pharmacy
Form 483 issued October 9, 2020 · Mount Laurel, New Jersey
- Inspection
- Sep 24 – Oct 9, 2020
- Investigator
- Russell J. Glapion
- Observations
- 4
- Pages
- 3
- FEI number
- 3002815949
In short: On October 9, 2020, FDA issued a Form 483 with 4 observations to Stokes Pharmacy in Mount Laurel, New Jersey (FEI 3002815949) after an inspection that ran Sep 24 – Oct 9, 2020. The investigator was Russell J. Glapion. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) 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 211.100
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 production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Stokes Pharmacy?
Russell J. Glapion is named on this Form 483, for the inspection of Sep 24 – Oct 9, 2020. Each investigator has a profile showing what they cite most.
When was Stokes Pharmacy inspected by FDA?
The inspection ran Sep 24 – Oct 9, 2020, and the Form 483 is dated October 9, 2020.
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.