FDA Inspection
Emerson HospitalEmerson Hospital – FDA Inspection, Jan 13, 2015
Record Details
This FDA Inspection record concerns Emerson Hospital, with an inspection on January 13, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Emerson Hospital
- Inspection Date
- January 13, 2015
- Product Type
- Biologics
View Company Profile
ID · 343c3524-a76a-4c99-9af8-40f11d00d163
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916284
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Emerson Hospital
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2025 | VAI | New England District Office | Blood and Blood Products |
| 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 |
| March 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Emerson Hospital
- FDA Inspection 1277644 - 2025-08-06
- FDA Inspection 1202980 - 2023-03-30
- FDA Inspection 1078912 - 2019-02-04
- FDA Inspection 1010013 - 2017-04-13
- FDA Inspection 822790 - 2013-03-13
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