Jeffreys Drug Store
Form 483 issued August 4, 2017 · Canonsburg, Pennsylvania
- Inspection
- Jul 25 – Aug 4, 2017
- Investigator
- Lisa B. Orr
- Observations
- 3
- Pages
- 4
- FEI number
- 3012080718
In short: On August 4, 2017, FDA issued a Form 483 with 3 observations to Jeffreys Drug Store in Canonsburg, Pennsylvania (FEI 3012080718) after an inspection that ran Jul 25 – Aug 4, 2017. The investigator was Lisa B. Orr. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
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 3 observations on this Form 483, mostly about facilities & equipment 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 Jul 25 – Aug 4, 2017. Each investigator has a profile showing what they cite most.
When was Jeffreys Drug Store inspected by FDA?
The inspection ran Jul 25 – Aug 4, 2017, and the Form 483 is dated August 4, 2017.
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.