First Call Pharmacy, LLC
Form 483 issued August 2, 2017 · Kenner, Louisiana
- Inspection
- Jul 25 – Aug 2, 2017
- Investigator
- Francis Guidry
- Observations
- 5
- Pages
- 2
- FEI number
- 3005011132
In short: On August 2, 2017, FDA issued a Form 483 with 5 observations to First Call Pharmacy, LLC in Kenner, Louisiana (FEI 3005011132) after an inspection that ran Jul 25 – Aug 2, 2017. The investigator was Francis Guidry. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.28 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing were…
- 02
Personnel engaged in aseptic processing were…
- 03
Personnel engaged in aseptic processing were observed with exposed skin…
- 04
The facility is designed and/or operated in a way that permits…
This inspection in context
Francis Guidry
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Louisiana.
The firmFirst Call Pharmacy, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at First Call Pharmacy, LLC?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected First Call Pharmacy, LLC?
Francis Guidry is named on this Form 483, for the inspection of Jul 25 – Aug 2, 2017. Each investigator has a profile showing what they cite most.
When was First Call Pharmacy, LLC inspected by FDA?
The inspection ran Jul 25 – Aug 2, 2017, and the Form 483 is dated August 2, 2017.
How do I get the full Form 483 for First Call Pharmacy, LLC?
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.