FDA Inspection
Apozeal Pharmaceuticals Inc.Apozeal Pharmaceuticals Inc. – FDA Inspection, Apr 5, 2017
Record Details
This FDA Inspection record concerns Apozeal Pharmaceuticals Inc., with an inspection on April 5, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christina K. Theodorou (FDA Associated Person)
- Lisa B. Orr (Issuing Officer)
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ID · 1d07c90c-d4fb-493d-b5b8-6487463129b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026757
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Apozeal Pharmaceuticals Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2025 | OAI | Philadelphia District Office | Drug Quality Assurance |
| December 15, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 9, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2018 | OAI | Philadelphia District Office | Generic Drug Evaluation |
Other documents for Apozeal Pharmaceuticals Inc.
- FDA Inspection 1287054 - 2025-10-15
- FDA Inspection 1161191 - 2021-12-15
- FDA Inspection 1085686 - 2019-04-09
- FDA Inspection 1073461 - 2018-11-09
- FDA Inspection 1060369 - 2018-07-26
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