FDA Inspection
Pine Pharmaceuticals, LLCPine Pharmaceuticals, LLC – FDA Inspection, Sep 30, 2024
Record Details
This FDA Inspection record concerns Pine Pharmaceuticals, LLC, with an inspection on September 30, 2024, issued by the New York District Office, covering human drugs.
View Company Profile
ID · b26b3e1e-7f23-4119-bccc-18b78849777b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1246936
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pine Pharmaceuticals, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | New York District Office | |
| September 19, 2023 | OAI | 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 |
Other documents for Pine Pharmaceuticals, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.