FDA Inspection
Pine Pharmaceuticals, LLCPine Pharmaceuticals, LLC – FDA Inspection, May 14, 2021
Record Details
This FDA Inspection record concerns Pine Pharmaceuticals, LLC, with an inspection on May 14, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pine Pharmaceuticals, LLC
- Inspection Date
- May 14, 2021
- Product Type
- Drugs
View Company Profile
ID · 1ef3f8d9-d6da-4178-8af3-44d2818de3d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1141929
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
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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 | |
| 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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