FDA Inspection
AACE Pharmaceuticals, Inc.AACE Pharmaceuticals, Inc. – FDA Inspection, Nov 22, 2024
Record Details
This FDA Inspection record concerns AACE Pharmaceuticals, Inc., with an inspection on November 22, 2024, issued by the New Jersey District Office, covering human drugs.
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ID · 4c0a9784-f9fb-4207-8f8a-5586ac70828f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1254783
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of AACE Pharmaceuticals, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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