Form FDA 483 · Issued 2025-11-14
Pine Pharmaceuticals LLC — FDA Form 483 Analysis
FEI: 3010943533 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: David K. Chen
FDA Form 483 issued to Pine Pharmaceuticals LLC (FEI 3010943533) on 2025-11-14 following an inspection of its outsourcing facility operations in New York. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identification of Each Lot in Each Shipment
Inspector Observation Language: "Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures]. Specifically, observed during inspection of Pine Pharmaceuticals LLC on 2025-11-14."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.165(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Sampling and testing plans not described
Inspector Observation Language: "Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested]. Specifically, observed during inspection of Pine Pharmaceuticals LLC on 2025-11-14."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #3 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Personnel dating/signing equipment log
Inspector Observation Language: "The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, observed during inspection of Pine Pharmaceuticals LLC on 2025-11-14."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #4 · 21 CFR 211.188(b)(10)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Sampling Performed
Inspector Observation Language: "The batch production and control records are deficient in that they do not include documentation of sampling performed. Specifically, observed during inspection of Pine Pharmaceuticals LLC on 2025-11-14."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.