Firm Record

Pine Pharmaceuticals, LLC findings history

34 findings from 6 inspection documents published by regulators. Each row below says what its date means.

US FDA 2021-09-24 ~ 2026-01-22 6 documents 34 findings

Areas cited

Aseptic processing and sterility assuranceMaterial and supplier controlLabeling and packagingProcess validationTraining and personnelRegulatory reporting and change controlLaboratory and QC controlsDeviation, CAPA, and investigationQuality unit oversightOther quality systemEquipment and facilityContamination controlComputer system validation

Published inspection documents

2026-01-22 US FDA 5 findingsProcess validation · Training and personnel · Deviation, CAPA, and investigation · Other quality system · Aseptic processing and sterility assurance Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 2025-02-12 US FDA 9 findingsAseptic processing and sterility assurance · Material and supplier control · Labeling and packaging · Process validation · Contamination control Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. 2024-01-17 US FDA 5 findingsRegulatory reporting and change control · Labeling and packaging · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls Your outsourcing facility has not submitted a report to FDA identifying all products compounded during the previous six month period as required by section 503B(b)(2)(A). 2024-01-17 US FDA 3 findingsTraining and personnel · Labeling and packaging · Aseptic processing and sterility assurance Employees engaged in the processing of a drug product lack the training required to perform their assigned functions. 2023-11-01 US FDA 7 findingsRegulatory reporting and change control · Quality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period. 2021-09-24 US FDA 5 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls · Quality unit oversight Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

About this page

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Pine Pharmaceuticals, LLC — including inspection classifications Browse by document Go to Findings search