# Pharmalogic New York City, LLC – FDA 483, Aug 19, 2026

Source: https://www.keypedia.com/records/483/pharmalogic-new-york-city-llc/800b5cb8-e5a1-4ec6-a40b-80dc8a513ae4

> FDA 483 for Pharmalogic New York City, LLC on August 19, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalogic New York City, LLC
- Inspection Date: 2026-08-19
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Pharmalogic New York City, LLC, a PET drug manufacturer in Bronx, NY, revealed a significant deficiency in the firm's corrective action procedures. The company failed to take appropriate corrective actions for out-of-specification results from Bacterial Endotoxin Tests and environmental/personnel monitoring, often attributing failures to unconfirmed laboratory errors or concluding no impact without establishing root causes. This indicates a systemic issue in their quality control and investigation processes.

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- [483 - 2024-01-12](https://www.keypedia.com/records/483/pharmalogic-new-york-city-llc/caff468a-fc15-4bf1-959d-ea00171eef04) — date: January 12, 2024

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.keypedia.com/companies/pharmalogic-new-york-city-llc/61eea767-7b5c-4f6b-85b9-8f03eabb1d24

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