FDA Inspection
Polansky, Francis, M.D., IncPolansky, Francis, M.D., Inc – FDA Inspection, Jul 8, 2016
Record Details
This FDA Inspection record concerns Polansky, Francis, M.D., Inc, with an inspection on July 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Polansky, Francis, M.D., Inc
- Inspection Date
- July 8, 2016
- Product Type
- Biologics
View Company Profile
ID · 86be9a90-2208-45fb-910e-ada8c70e6b6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979895
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
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Other FDA inspections of Polansky, Francis, M.D., Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | Not classified | San Francisco District Office | |
| January 14, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Polansky, Francis, M.D., Inc
- FDA Inspection 1266985 - 2025-03-21
- FDA Inspection 1119716 - 2020-01-14
- FDA Inspection 829287 - 2013-04-18
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