Jeffreys Drug Store
Form 483 issued March 4, 2016 · Canonsburg, Pennsylvania
- Inspection
- Feb 9, 2016
- Investigator
- Lisa B. Orr
- Observations
- 8
- Pages
- 3
- FEI number
- 3012080718
In short: On March 4, 2016, FDA issued a Form 483 with 8 observations to Jeffreys Drug Store in Canonsburg, Pennsylvania (FEI 3012080718) after an inspection that ran Feb 9, 2016. The investigator was Lisa B. Orr. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 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 batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Lisa B. Orr
9 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJeffreys Drug Store history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jeffreys Drug Store?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 Jeffreys Drug Store?
Lisa B. Orr is named on this Form 483, for the inspection of Feb 9, 2016. Each investigator has a profile showing what they cite most.
When was Jeffreys Drug Store inspected by FDA?
The inspection ran Feb 9, 2016, and the Form 483 is dated March 4, 2016.
How do I get the full Form 483 for Jeffreys Drug Store?
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.