FDA Inspection
Roswell Park Cancer Institute Corporation. Div. of PathologyRoswell Park Cancer Institute Corporation. Div. of Pathology – FDA Inspection, Jun 17, 2011
Record Details
This FDA Inspection record concerns Roswell Park Cancer Institute Corporation. Div. of Pathology, with an inspection on June 17, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 17, 2011
- Product Type
- Biologics
View Company Profile
ID · 30483b1c-39cf-4a67-ae27-4da16dda57aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730322
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Roswell Park Cancer Institute Corporation. Div. of Pathology
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 13, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 1, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Roswell Park Cancer Institute Corporation. Div. of Pathology
- FDA Inspection 1284298 - 2025-09-19
- FDA Inspection 1200624 - 2023-03-13
- FDA Inspection 1084076 - 2019-03-01
- FDA Inspection 998259 - 2017-01-13
- FDA Inspection 908088 - 2014-12-19
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