Company
United StatesBCG Medical Inc, Laguna Niguel, CA – FDA Inspections
Inspection records and compliance data for BCG Medical Inc in Laguna Niguel, California. 1 FDA inspection on record, 1 Form 483, last inspected September 13, 2018.
Company Profile
This profile covers BCG Medical Inc based in Laguna Niguel, California, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected September 13, 2018.
Most cited issue areas
- Design review - documentation1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1065934 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BCG Medical Inc
FEI Number
3009380895
Address
23052 Andria Pl, Laguna Niguel, California 92677, United States
Country
United States
ID: 2222b582-f5d7-4d17-826f-1f4e560278d4