Dorneyville Pharmacy
Form 483 issued February 9, 2020 · Allentown, Pennsylvania
- Inspection
- Feb 9, 2020
- Investigator
- James M. Mason
- Observations
- 14
- Pages
- 8
- FEI number
- 3005231215
In short: On February 9, 2020, FDA issued a Form 483 with 14 observations to Dorneyville Pharmacy in Allentown, Pennsylvania (FEI 3005231215) after an inspection that ran Feb 9, 2020. The investigator was James M. Mason. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by materials.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each lot of dmg product containers and closmes is not withheld from use until the lot…
- 02
Procedmes designed to prevent microbiological contamination of d.mg products pmporting to be sterile are not…
- 03
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 14 observations on this Form 483, mostly about materials, production and laboratory controls. 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?
James M. Mason is named on this Form 483, for the inspection of Feb 9, 2020. Each investigator has a profile showing what they cite most.
When was Dorneyville Pharmacy inspected by FDA?
The inspection ran Feb 9, 2020, and the Form 483 is dated February 9, 2020.
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.