Company
United StatesPatientSafeSolutions, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for PatientSafeSolutions, Inc. in San Diego, California. 2 FDA inspections on record, last inspected August 29, 2019.
Company Profile
This profile covers PatientSafeSolutions, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 20, 2013. Last inspected August 29, 2019.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- DMR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1106733 |
| September 20, 2013 | VAI | Biologics · Blood and Blood Products | 850157 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PatientSafeSolutions, Inc.
FEI Number
3006786205
Address
5375 Mira Sorrento Pl Ste 500, San Diego, California 92121, United States
Country
United States
ID: 0b446a70-1953-427c-9d1a-22b680e21fad