FDA Inspection
Sebela Women's Health Inc.Sebela Women's Health Inc. – FDA Inspection, Oct 13, 2023
Record Details
This FDA Inspection record concerns Sebela Women's Health Inc., with an inspection on October 13, 2023, issued by the Atlanta District Office.
- Company
- Sebela Women's Health Inc.
- Inspection Date
- October 13, 2023
View Company Profile
ID · 14c62626-d422-4966-b73e-fa4d78535f8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220388
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Sebela Women's Health Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Sebela Women's Health Inc.
- FDA Inspection 1221415 - 2023-10-13
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