Company
United StatesSebela Women's Health Inc., Roswell, GA – FDA Inspections
Inspection records and compliance data for Sebela Women's Health Inc. in Roswell, Georgia. 2 FDA inspections on record, 1 Form 483, last inspected October 13, 2023.
Company Profile
This profile covers Sebela Women's Health Inc. based in Roswell, Georgia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected October 13, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Actual vs. theoretical yields not determined1 inspection
- Complaint Handling Procedure1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 13, 2023 | NAI | Human Drugs · Bioresearch Monitoring | 1221415 |
| October 13, 2023 | VAI | Human Drugs | 1220388 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sebela Women's Health Inc.
FEI Number
3026478655
Address
645 Hembree Pkwy Ste I, Roswell, Georgia 30076, United States
Country
United States
ID: da01e005-1c2d-4804-8892-35e35e399ffa