FDA Inspection
Annovex Pharma, Inc.Annovex Pharma, Inc. – FDA Inspection, Sep 6, 2024
Record Details
This FDA Inspection record concerns Annovex Pharma, Inc., with an inspection on September 6, 2024, issued by the Baltimore District Office, covering human drugs.
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ID · 36ae300a-c916-4ad4-b937-d971e54facb0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1248991
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- FD&C Act 503B(b)(2)(A)Outsourcing facility, compounded drug report follow up
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(c)Records not made readily available to FDA
- FD&C Act 503B(a)(10)(A)Drug product labels, fails to include
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Annovex Pharma, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | Not classified | Baltimore District Office | Drug Quality Assurance |
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