FDA Inspection
Emerson HospitalEmerson Hospital – FDA Inspection, Aug 6, 2025
Record Details
This FDA Inspection record concerns Emerson Hospital, with an inspection on August 6, 2025, issued by the New England District Office, covering biologics.
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ID · b93241d8-d04e-4129-ab24-6b7592e95c9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277644
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 606.65(e)Following manufacturer's instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(b)SOPs for investigations, records
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(b)Required records
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Other FDA inspections of Emerson Hospital
9| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 13, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Emerson Hospital
- FDA Inspection 1202980 - 2023-03-30
- FDA Inspection 1078912 - 2019-02-04
- FDA Inspection 1010013 - 2017-04-13
- FDA Inspection 916284 - 2015-01-13
- FDA Inspection 822790 - 2013-03-13
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