Company
United StatesNorth Coast Medical Inc, Morgan Hill, CA – FDA Inspections
Inspection records and compliance data for North Coast Medical Inc in Morgan Hill, California. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 02, 2024.
Company Profile
This profile covers North Coast Medical Inc based in Morgan Hill, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 17, 2009. Last inspected August 2, 2024.
Most cited issue areas
- Design validation - simulated testing2 inspections
- Documentation2 inspections
- Procedures not adequately established or maintained2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1245520 |
| August 28, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1216094 |
| November 30, 2016 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 997734 |
| April 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 778263 |
| February 24, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 771852 |
| May 25, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 727010 |
| August 17, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 604821 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
North Coast Medical Inc
FEI Number
1000124207
Address
135 E Main Ave Ste 110, Morgan Hill, California 95037, United States
Country
United States
ID: 80f1489c-9064-4952-be62-4bbb49f16746