Footfalls Professional Pharmacy, Ltd.
Form 483 issued October 24, 2018 · Phoenix, Arizona
- Inspection
- Jul 9 – Oct 24, 2018
- Investigators
- Christopher M. Jenner· Nicholas L. Hunt
- Observations
- 9
- Pages
- 5
- FEI number
- 3014435648
In short: On October 24, 2018, FDA issued a Form 483 with 9 observations to Footfalls Professional Pharmacy, Ltd. in Phoenix, Arizona (FEI 3014435648) after an inspection that ran Jul 9 – Oct 24, 2018. The investigators were Christopher M. Jenner and Nicholas L. Hunt. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 7 of 9 observations.
Most cited: 21 CFR 211.165 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released finished products…
- 02
Your firm produced beta-lactam and non-beta-lactam drug products using shared equipment and utensils. There was inadequate…
- 03
Your firm does not use adequate disinfectant…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmFootfalls Professional Pharmacy, Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Footfalls Professional Pharmacy, Ltd.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Footfalls Professional Pharmacy, Ltd.?
Christopher M. Jenner and Nicholas L. Hunt are named on this Form 483, for the inspection of Jul 9 – Oct 24, 2018. Each investigator has a profile showing what they cite most.
When was Footfalls Professional Pharmacy, Ltd. inspected by FDA?
The inspection ran Jul 9 – Oct 24, 2018, and the Form 483 is dated October 24, 2018.
How do I get the full Form 483 for Footfalls Professional Pharmacy, Ltd.?
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.