Infusion Partners, 11C
Form 483 issued January 26, 2018 · Canf i e ld, Ohio
- Inspection
- Jan 22 – Jan 26, 2018
- Investigators
- Lauren N. Howard· Matthew B. Casale
- Observations
- 10
- Pages
- 6
- FEI number
- 3013995728
In short: On January 26, 2018, FDA issued a Form 483 with 10 observations to Infusion Partners, 11C in Canf i e ld, Ohio (FEI 3013995728) after an inspection that ran Jan 22 – Jan 26, 2018. The investigators were Lauren N. Howard and Matthew B. Casale.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had visibly…
- 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 conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 04FDCA 501(a)(2)(A)
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmInfusion Partners, 11C 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 Infusion Partners, 11C?
FDA listed 10 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Infusion Partners, 11C?
Lauren N. Howard and Matthew B. Casale are named on this Form 483, for the inspection of Jan 22 – Jan 26, 2018. Each investigator has a profile showing what they cite most.
When was Infusion Partners, 11C inspected by FDA?
The inspection ran Jan 22 – Jan 26, 2018, and the Form 483 is dated January 26, 2018.
How do I get the full Form 483 for Infusion Partners, 11C?
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.