FDA Inspection
Apozeal Pharmaceuticals Inc.Apozeal Pharmaceuticals Inc. – FDA Inspection, Feb 7, 2018
Record Details
This FDA Inspection record concerns Apozeal Pharmaceuticals Inc., with an inspection on February 7, 2018, issued by the Philadelphia District Office, covering human drugs.
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ID · cac43cea-0ad1-4497-8efd-7c750e795e59
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1040076
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
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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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