FDA Inspection
Pine Pharmaceuticals, LLCPine Pharmaceuticals, LLC – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Pine Pharmaceuticals, LLC, with an inspection on April 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0f8a59f1-ed7f-4ae2-9b0b-4ca6b4758585
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049641
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
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Other FDA inspections of Pine Pharmaceuticals, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | New York District Office | |
| September 30, 2024 | OAI | New York District Office | Drug Quality Assurance |
| September 19, 2023 | OAI | Drug Quality Assurance | |
| May 14, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 9, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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