Firm Record
Pine Pharmaceuticals, LLC findings history
47 findings from 7 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceProcess validationTraining and personnelMaterial and supplier controlDeviation, CAPA, and investigationLabeling and packagingRegulatory reporting and change controlOther quality systemLaboratory and QC controlsQuality unit oversightDocumentation and recordsValidation and qualificationComplaint and recall handlingEquipment and facilityContamination controlComputer system validation
Published inspection documents
2026-10-06
US FDA
13 findingsDocumentation and records · Aseptic processing and sterility assurance · Complaint and recall handling · Validation and qualification · Deviation, CAPA, and investigation · Other quality system · Process validation · Training and personnel Your firm failed to determine actual yield and percentages of theoretical yield at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product [21 CFR 211.103]. Specifically, in addition to the deficiencies noted in the visual inspection reject rate calculations, our review of the data collected during the inspection revealed that the acceptable yield range established in your batch records permits yields as low as (b)(4) , allowing up to (b)(4) of a batch to be rejected without triggering an investigation, yet the batch can still be released for distribution. Furthermore, although (b)(4) meets the definition of particulate matter as “mobile undissolved particles, other than air bubbles, unintentionally present in solutions” in SOP-061 (Visual Inspection Finished Product, Rev. 23), it was classified as a “minor” defect in ISSUE-2025-0011, without scientific justification or a clear procedural basis in SOP-061. By classifying (b)(4) as a minor defect rather than as particulate matter, (b)(4) rejects are counted only as part of the minor reject rate limit, bypassing both the major defect category trigger and the separate particulate category trigger entirely. Additionally, certain “cosmetic” defects are allowed to be returned to the batch, despite SOP-061 containing no definition, criteria, or examples of what constitutes a “cosmetic” defect, nor does it specify which cosmetic defect may be returned to the batch and which must be rejected. View the regulator's official source
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. View the regulator's official source
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. View the regulator's official source
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). View the regulator's official source
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. View the regulator's official source
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. View the regulator's official source
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. View the regulator's official source
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 2026-10-20, 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.
