Inspection Record

Pine Pharmaceuticals, LLC — FDA 483 Findings

US FDAInspected 2018-10-24Published 2024-01-17 3 findingsTraining and personnelLabeling and packagingAseptic processing and sterility assurance

Inspectors Rachael A. MoliverThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Training and personnel

Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.

2Labeling and packaging

Strict control is not exercised over labeling issued for use in drug product labeling operations.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and foJlowed.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

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.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

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Pine Pharmaceuticals, LLC company profile — full history US FDA documents, 2024 Go to Findings search