Avenue Pharmacy fnc. dba Pathway Pharmacy
Form 483 issued December 6, 2019 · Ocala, Florida
- Inspection
- Dec 4 – Dec 6, 2019
- Investigator
- Patrick L. Foster
- Observations
- 3
- Pages
- 2
- FEI number
- 3014853350
In short: On December 6, 2019, FDA issued a Form 483 with 3 observations to Avenue Pharmacy fnc. dba Pathway Pharmacy in Ocala, Florida (FEI 3014853350) after an inspection that ran Dec 4 – Dec 6, 2019. The investigator was Patrick L. Foster. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
- 02
Your firm produced drugs while construction is underway in an adjacent area without adequate controls to…
- 03
Your firm released drug product in which the strength differs from, or its purity or quality…
This inspection in context
Patrick L. Foster
1 document · 2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmAvenue Pharmacy fnc. dba Pathway Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avenue Pharmacy fnc. dba Pathway Pharmacy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Avenue Pharmacy fnc. dba Pathway Pharmacy?
Patrick L. Foster is named on this Form 483, for the inspection of Dec 4 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Avenue Pharmacy fnc. dba Pathway Pharmacy inspected by FDA?
The inspection ran Dec 4 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 483 for Avenue Pharmacy fnc. dba Pathway 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.