FDA Inspection
Polcz Fertility Lab, LLCPolcz Fertility Lab, LLC – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns Polcz Fertility Lab, LLC, with an inspection on April 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Colleen M. Aspinwall (Issuing Officer)
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ID · e240d541-6578-4d6a-b4ff-78f0e17cb6c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048798
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
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Other FDA inspections of Polcz Fertility Lab, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 27, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 10, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 27, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Polcz Fertility Lab, LLC
- FDA Inspection 1222743 - 2023-11-14
- FDA Inspection 1172846 - 2022-06-27
- FDA Inspection 941582 - 2015-09-10
- FDA Inspection 838539 - 2013-06-27
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