Company
United StatesBloomex International, Inc., Lanesville, NY – FDA Inspections
Inspection records and compliance data for Bloomex International, Inc. in Lanesville, New York. 2 FDA inspections on record, last inspected July 02, 2012.
Company Profile
This profile covers Bloomex International, Inc. based in Lanesville, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected May 1, 2009. Last inspected July 2, 2012.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Lack of Written MDR Procedures2 inspections
- Management review - Lack of or inadequate procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 2, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 790206 |
| May 1, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 584472 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bloomex International, Inc.
FEI Number
2431678
Address
2157 Route 214, Lanesville, New York 12450, United States
Country
United States
ID: 10a4b55e-229a-4f0f-90a9-65bfe3ec5aaf