# FDA 483 - Pine Pharmaceuticals, LLC - September 19, 2023

Source: https://www.keypedia.com/records/483/pine-pharmaceuticals-llc/d1b3fbf6-be99-4916-bb8c-5c1c3116806e

> FDA 483 for Pine Pharmaceuticals, LLC on September 19, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2023-09-19
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 details significant deficiencies at an outsourcing facility, primarily concerning quality control, sterile manufacturing, and reporting.

**Quality Control Unit Deficiencies:**
The quality control unit lacks adequate authority and responsibility.
*   **EPI-CAINE 0.025%-0.75% INJ (IML) SDV, Lot# (b) (4):** Released despite 3% "all other defects" (including 5 visible particulate and 11 seal defects) without root cause investigation.
*   **TROPI-PHEN (b) (4) OPHTH SOL (15 mL) Lot# (b) (4):** Released after failing 1st and 2nd AQL inspections, following an unjustified procedure change reclassifying particulate matter from critical to major.
*   **Inadequate Acceptance Criteria:** No scientific justification for moving to a 2nd 100% Visual Inspection (VI) when 1st 100% and AQL fail. Multiple batches with critical defects (e.g., particulate matter) were released without proper identification or assurance of freedom from further particulate matter.

**Failure to Thoroughly Review Batch Failures:**
*   **LIDO-PHEN 1%-1.5% (IML) SDV Lot# (b) (4):** Released after failing two 100% visual and AQL inspections, then

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## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

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