FDA Inspection
Health Pharma USA LLCHealth Pharma USA LLC – FDA Inspection, Nov 18, 2025
Record Details
This FDA Inspection record concerns Health Pharma USA LLC, with an inspection on November 18, 2025, issued by the New Jersey District Office, covering foods & cosmetics.
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ID · b82ba075-b0a2-4780-bccf-68331789c815
Inspection Facts
- Inspection number
- 1281302
- FDA center
- Foods & Cosmetics
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 111.103Written procedures - establish; quality control operations
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.10(b)Hygienic practices
- 21 CFR 111.153Written procedures - follow; components
- 21 CFR 111.155(e)Components - contamination, deterioration, mix-ups
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.27(a)Equipment - design - appropriate and suitable
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
- 21 CFR 111.70(b)Specifications - components
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Other FDA inspections of Health Pharma USA LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 22, 2021 | 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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