Company
United StatesAmniSure International LLC, Boston, MA – FDA Inspections
Inspection records and compliance data for AmniSure International LLC in Boston, Massachusetts. 1 FDA inspection on record, last inspected November 18, 2010.
Company Profile
This profile covers AmniSure International LLC based in Boston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 18, 2010.
Most cited issue areas
- Lack of or inadequate procedures for labeling1 inspection
- Production processes1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 18, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 697628 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AmniSure International LLC
FEI Number
3005345832
Address
24 School St Fl 6, Boston, Massachusetts 02108, United States
Country
United States
ID: cec6f019-a1d5-4719-8662-a1a43eedf79e