FDA Inspection
Prisma Health Outsourcing FacilityPrisma Health Outsourcing Facility – FDA Inspection, Mar 3, 2023
Record Details
This FDA Inspection record concerns Prisma Health Outsourcing Facility, with an inspection on March 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 99fc5b1b-a014-485f-a46f-6d17dc0a5ec8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198795
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
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