FDA Inspection
Pine Pharmaceuticals, LLCPine Pharmaceuticals, LLC – FDA Inspection, Sep 19, 2023
Record Details
This FDA Inspection record concerns Pine Pharmaceuticals, LLC, with an inspection on September 19, 2023, covering drugs.
- Company
- Pine Pharmaceuticals, LLC
- Inspection Date
- September 19, 2023
- Product Type
- Drugs
View Company Profile
ID · 22f4e0f7-f43d-455f-8d62-ad77733fc626
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1218206
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Approve or reject components, products
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 503B(b)(2)(A)Outsourcing facility, compounded drug report follow up
- FDCA 501(a)(2)(A)Personnel, blocked or disrupted first air
- FDCA 501(a)(2)(A)Production areas, difficult to clean/particle generating
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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 |
| May 14, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2018 | VAI | 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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