FDA Inspection
Dr. Louis R. ManaraDr. Louis R. Manara – FDA Inspection, Jan 16, 2014
Record Details
This FDA Inspection record concerns Dr. Louis R. Manara, with an inspection on January 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Dr. Louis R. Manara
- Inspection Date
- January 16, 2014
- Product Type
- Biologics
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ID · 4a430880-8bf8-4bd6-a0f6-445d7dd4a750
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862311
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dr. Louis R. Manara
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 21, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| January 28, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 12, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Dr. Louis R. Manara
- FDA Inspection 1236701 - 2024-03-26
- FDA Inspection 1206226 - 2023-05-23
- FDA Inspection 1152479 - 2021-10-21
- FDA Inspection 1116668 - 2020-01-28
- FDA Inspection 1039896 - 2018-01-12
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