FDA Inspection
Children's Hospital Medical Center of AkronChildren's Hospital Medical Center of Akron – FDA Inspection, Dec 5, 2016
Record Details
This FDA Inspection record concerns Children's Hospital Medical Center of Akron, with an inspection on December 5, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 5, 2016
- Product Type
- Biologics
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ID · 84530ba0-f35d-4a79-be99-095149abb710
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993739
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Children's Hospital Medical Center of Akron
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 4, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 29, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 10, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Children's Hospital Medical Center of Akron
- FDA Inspection 1260019 - 2025-01-31
- FDA Inspection 1164146 - 2022-03-04
- FDA Inspection 1073634 - 2018-11-29
- FDA Inspection 904140 - 2014-11-20
- FDA Inspection 809246 - 2012-11-10
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