Prisma Health Outsourcing Facility
Form 483 issued March 3, 2023 · Simpsonvi l le, South Carolina
- Inspection
- Feb 23 – Mar 3, 2023
- Investigator
- Camerson E. Moore
- Observations
- 4
- Pages
- 3
- FEI number
- 3015162096
In short: On March 3, 2023, FDA issued a Form 483 with 4 observations to Prisma Health Outsourcing Facility in Simpsonvi l le, South Carolina (FEI 3015162096) after an inspection that ran Feb 23 – Mar 3, 2023. The investigator was Camerson E. Moore. Most observations concern production and facilities & equipment.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmPrisma Health Outsourcing Facility history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prisma Health Outsourcing Facility?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Prisma Health Outsourcing Facility?
Camerson E. Moore is named on this Form 483, for the inspection of Feb 23 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was Prisma Health Outsourcing Facility inspected by FDA?
The inspection ran Feb 23 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
How do I get the full Form 483 for Prisma Health Outsourcing Facility?
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.