FDA Inspection
Pharmaloz Manufacturing Inc.Pharmaloz Manufacturing Inc. – FDA Inspection, Apr 14, 2025
Record Details
This FDA Inspection record concerns Pharmaloz Manufacturing Inc., with an inspection on April 14, 2025, issued by the Philadelphia District Office, covering human drugs.
- Person
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ID · 79ce2a80-868b-4406-aa13-eeddb6dbea6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1266720
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pharmaloz Manufacturing Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1215503 - 2023-08-16
- FDA Inspection 1056562 - 2018-06-21
- FDA Inspection 879146 - 2014-05-16
- FDA Inspection 706645 - 2011-01-20
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