FDA Inspection
Pharmaloz Manufacturing Inc.Pharmaloz Manufacturing Inc. – FDA Inspection, Jun 21, 2018
Record Details
This FDA Inspection record concerns Pharmaloz Manufacturing Inc., with an inspection on June 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 952ed9b2-659e-4de4-872c-05f36aa21aec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056562
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(4)Data secured in course of each test
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Other FDA inspections of Pharmaloz Manufacturing Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2025 | VAI | Philadelphia District Office | Drug Quality Assurance |
| August 16, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmaloz Manufacturing Inc.
- FDA Inspection 1266720 - 2025-04-14
- FDA Inspection 1215503 - 2023-08-16
- FDA Inspection 879146 - 2014-05-16
- FDA Inspection 706645 - 2011-01-20
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