FDA Inspection
Health Pharma USA LLCHealth Pharma USA LLC – FDA Inspection, Sep 22, 2021
Record Details
This FDA Inspection record concerns Health Pharma USA LLC, with an inspection on September 22, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Health Pharma USA LLC
- Inspection Date
- September 22, 2021
- Product Type
- Drugs
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ID · b2d83c39-c9a0-407e-9e47-4b99a7f05942
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152299
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)(1)Description and Identification of Samples
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Health Pharma USA LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2025 | Not classified | New Jersey District Office | Drug Quality Assurance |
| July 3, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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