FDA Inspection
Hamamatsu/Queen's PET Imaging Center, LLCHamamatsu/Queen's PET Imaging Center, LLC – FDA Inspection, Oct 11, 2024
Record Details
This FDA Inspection record concerns Hamamatsu/Queen's PET Imaging Center, LLC, with an inspection on October 11, 2024, issued by the San Francisco District Office, covering human drugs.
- Inspection Date
- October 11, 2024
- Product Type
- Human Drugs
- Person
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ID · 73b0010c-ae77-4b79-a9a7-48a8dc0dd534
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1251634
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of Hamamatsu/Queen's PET Imaging Center, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 21, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 15, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 14, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Hamamatsu/Queen's PET Imaging Center, LLC
- FDA Inspection 1074330 - 2018-12-13
- FDA Inspection 1057806 - 2018-05-21
- FDA Inspection 973798 - 2016-06-15
- FDA Inspection 928275 - 2015-05-14
- FDA Inspection 855279 - 2013-11-08
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