Dorneyville Pharmacy
Form 483 issued September 28, 2018 · Allentown, Pennsylvania
- Inspection
- Aug 27 – Sep 28, 2018
- Investigator
- Jose M. Cayuela
- Observations
- 2
- Pages
- 1
- FEI number
- 3005231215
In short: On September 28, 2018, FDA issued a Form 483 with 2 observations to Dorneyville Pharmacy in Allentown, Pennsylvania (FEI 3005231215) after an inspection that ran Aug 27 – Sep 28, 2018. The investigator was Jose M. Cayuela. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The fi nal containers/closures used for drug product intended to be…
- 02
You used a non-pharmaceutical grade component in the formulation…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmDorneyville Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dorneyville Pharmacy?
FDA listed 2 observations on this Form 483, mostly about production and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Dorneyville Pharmacy?
Jose M. Cayuela is named on this Form 483, for the inspection of Aug 27 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Dorneyville Pharmacy inspected by FDA?
The inspection ran Aug 27 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
How do I get the full Form 483 for Dorneyville 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.