FDA Inspection
Computer Programs & Systems IncComputer Programs & Systems Inc – FDA Inspection, Mar 26, 2018
Record Details
This FDA Inspection record concerns Computer Programs & Systems Inc, with an inspection on March 26, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Jason D Abel (Issuing Officer)
- Wendy R. Blame (Issuing Officer)
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ID · 99ebabb8-0a5f-4365-9988-81760613e2be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045804
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Computer Programs & Systems Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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