FDA Inspection
Nicklaus Children's HospitalNicklaus Children's Hospital – FDA Inspection, Aug 3, 2016
Record Details
This FDA Inspection record concerns Nicklaus Children's Hospital, with an inspection on August 3, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Nicklaus Children's Hospital
- Inspection Date
- August 3, 2016
- Product Type
- Biologics
View Company Profile
ID · 264ecf4c-67f6-4d7a-bdc7-611029e4a896
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984201
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 610.46(b)(3)Notify MD, Legal Rep, or Relative of Transf Recip [Consign]
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.170(a)Adverse reaction - Disposition of Reports
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nicklaus Children's Hospital
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2024 | Not classified | Florida District Office | |
| February 23, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 7, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 22, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Nicklaus Children's Hospital
- FDA Inspection 1253722 - 2024-11-06
- FDA Inspection 1198477 - 2023-02-23
- FDA Inspection 1102551 - 2019-08-07
- FDA Inspection 887839 - 2014-05-22
- FDA Inspection 727131 - 2011-05-20
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