Stokes Pharmacy
Form 483 issued May 29, 2018 · Mount Laurel, New Jersey
- Inspection
- May 29, 2018
- Investigator
- Russell J. Glapion
- Observations
- 5
- Pages
- 3
- FEI number
- 3002815949
In short: On May 29, 2018, FDA issued a Form 483 with 5 observations to Stokes Pharmacy in Mount Laurel, New Jersey (FEI 3002815949) after an inspection that ran May 29, 2018. The investigator was Russell J. Glapion. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Results of stability testing are not used in determining…
- 03
Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures…
- 04
Observation 4: scanned text, readable in the full document.
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 211.165
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 laboratory controls, production and packaging & labeling. 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 May 29, 2018. Each investigator has a profile showing what they cite most.
When was Stokes Pharmacy inspected by FDA?
The inspection ran May 29, 2018, and the Form 483 is dated May 29, 2018.
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.