Central Admixture Pharmacy Services Inc
Form 483 issued May 24, 2021 · Harahan, Louisiana
- Inspection
- May 3 – May 24, 2021
- Investigator
- Claire M. Minden
- Observations
- 4
- Pages
- 4
- FEI number
- 3005292119
In short: On May 24, 2021, FDA issued a Form 483 with 4 observations to Central Admixture Pharmacy Services Inc in Harahan, Louisiana (FEI 3005292119) after an inspection that ran May 3 – May 24, 2021. The investigator was Claire M. Minden.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02FDCA 501(a)(2)(A)
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 03FDCA 501(a)(2)(A)
Personnel touched equipment or other smfaces located outside of the ISO 5 classified aseptic processing area…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmCentral Admixture Pharmacy Services Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Central Admixture Pharmacy Services Inc?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services Inc?
Claire M. Minden is named on this Form 483, for the inspection of May 3 – May 24, 2021. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services Inc inspected by FDA?
The inspection ran May 3 – May 24, 2021, and the Form 483 is dated May 24, 2021.
How do I get the full Form 483 for Central Admixture Pharmacy Services Inc?
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.