Company
United StatesOraWell USA, Philadelphia, PA – FDA Inspections
Inspection records and compliance data for OraWell USA in Philadelphia, Pennsylvania. 2 FDA inspections on record (1 OAI), last inspected December 15, 2011.
Company Profile
This profile covers OraWell USA based in Philadelphia, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2011. Last inspected December 15, 2011.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Design plans - Lack of or inadequate1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2011 | NAI | Biologics · Blood and Blood Products | 762285 |
| August 5, 2011 | OAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 733405 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OraWell USA
FEI Number
3008996355
Address
7514 Algon Ave, Apt A, Philadelphia, Pennsylvania 19111, United States
Country
United States
ID: e2cbda70-7cb7-440c-86fe-f19848f0a2ae