FDA Inspection
Mountain View Hospital, LLCMountain View Hospital, LLC – FDA Inspection, Sep 10, 2014
Record Details
This FDA Inspection record concerns Mountain View Hospital, LLC, with an inspection on September 10, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Mountain View Hospital, LLC
- Inspection Date
- September 10, 2014
- Product Type
- Biologics
View Company Profile
ID · f6df01ed-f986-46f2-b017-4937eca49763
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 896777
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 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 Mountain View Hospital, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2024 | Not classified | Seattle District Office | |
| July 31, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 24, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mountain View Hospital, LLC
- FDA Inspection 1256330 - 2024-11-21
- FDA Inspection 1105826 - 2019-07-31
- FDA Inspection 1026187 - 2017-08-10
- FDA Inspection 934445 - 2015-06-24
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