# FDA 483 - Pine Pharmaceuticals, LLC - May 14, 2021

Source: https://www.keypedia.com/records/483/pine-pharmaceuticals-llc/9fc4c1f8-9b94-4754-a9bc-05e72748fcda

> FDA 483 for Pine Pharmaceuticals, LLC on May 14, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2021-05-14
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA conducted an inspection of Pine Pharmaceuticals, LLC, an outsourcing facility, from May 3 to May 14, 2021. The inspection identified several critical deficiencies, indicating non-compliance with the Federal Food, Drug, and Cosmetic Act regarding the manufacturing of sterile drug products.

Key violations included a systemic failure to thoroughly review and adequately investigate out-of-specification (OOS) potency results for drug products. Multiple instances showed product lots being released despite initial OOS findings, often without sufficient scientific justification for invalidating initial tests or relying on unvalidated test methods.

Significant issues were also observed in procedures designed to prevent microbiological contamination during sterile processing. These included inadequate material sanitization before introduction into sterile environments, lack of environmental monitoring during critical aseptic steps, insufficient dynamic smoke studies for various filling processes, and observed lapses in operator aseptic technique. Many of these aseptic process control issues were noted as repeated objectionable conditions from prior 2018 inspections.

Further observations highlighted that the Quality Control unit failed to adequately approve and reject procedures impacting product identity, strength, quality, and purity, specifically releasing products based on unvalidated test methods. This particular observation was a repeated condition from 2015 and a 2016 Warning Letter. Additionally, laboratory controls lacked essential growth promotion testing for in-house prepared media used in aseptic process simulations, and calibration records for critical sterilization equipment were not maintained.

Pine Pharmaceuticals, LLC is required to implement comprehensive corrective and preventive actions to address these serious findings to ensure full compliance with regulatory standards and the safety and quality of its sterile drug products.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

Company: https://www.keypedia.com/companies/pine-pharmaceuticals-llc/03870efc-b074-462a-8520-e5cadc945149

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d