Company
United StatesBioserv Corporation, San Diego, CA – FDA Inspections
Inspection records and compliance data for Bioserv Corporation in San Diego, California. 7 FDA inspections on record, 1 Form 483, last inspected January 12, 2023.
Company Profile
This profile covers Bioserv Corporation based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected June 24, 2009. Last inspected January 12, 2023.
Most cited issue areas
- Establish reliability of supplier"s C of A1 inspection
- Procedure Deviations Recorded and Justified1 inspection
- Validation lacking for sterile drug products1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 12, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1195989 |
| July 31, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1022355 |
| January 23, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 863803 |
| October 24, 2012 | NAI | Human Drugs · Drug Quality Assurance | 804269 |
| December 7, 2011 | VAI | Human Drugs · Drug Quality Assurance | 756094 |
| April 12, 2010 | NAI | Human Drugs · Drug Quality Assurance | 656899 |
| June 24, 2009 | NAI | Human Drugs · Drug Quality Assurance | 592023 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bioserv Corporation
FEI Number
2027352
Address
5340 Eastgate Mall, San Diego, California 92121, United States
Country
United States
ID: 1d9b6bef-b61b-40ae-8d76-978a820dd6dc