FDA Inspection
Roper St. Francis HealthcareRoper St. Francis Healthcare – FDA Inspection, Aug 5, 2011
Record Details
This FDA Inspection record concerns Roper St. Francis Healthcare, with an inspection on August 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Roper St. Francis Healthcare
- Inspection Date
- August 5, 2011
- Product Type
- Biologics
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ID · 5a869865-9e86-4940-9573-9a309823a2bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741069
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Roper St. Francis Healthcare
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2025 | Not classified | Atlanta District Office | |
| March 9, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 25, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Roper St. Francis Healthcare
- FDA Inspection 1272023 - 2025-05-07
- FDA Inspection 1164602 - 2022-03-09
- FDA Inspection 1076681 - 2018-12-13
- FDA Inspection 1014038 - 2017-05-25
- FDA Inspection 931444 - 2015-06-23
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