FDA Inspection
Hospital Damas, Inc.Hospital Damas, Inc. – FDA Inspection, Feb 23, 2017
Record Details
This FDA Inspection record concerns Hospital Damas, Inc., with an inspection on February 23, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Adalberto Cajigas (Issuing Officer)
- Laura E. Garcia (Issuing Officer)
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ID · 03fbb0f5-f1eb-4a1e-9f8b-c66b17e55882
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002968
- 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 Hospital Damas, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | Not classified | San Juan District Office | |
| April 6, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 22, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Hospital Damas, Inc.
- FDA Inspection 1268554 - 2025-04-09
- FDA Inspection 1167607 - 2022-04-06
- FDA Inspection 1077378 - 2018-12-13
- FDA Inspection 933496 - 2015-06-29
- FDA Inspection 818949 - 2013-02-22
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