# Pharmalogic New York City, LLC – FDA 483, Jan 12, 2024

Source: https://www.keypedia.com/records/483/pharmalogic-new-york-city-llc/caff468a-fc15-4bf1-959d-ea00171eef04

> FDA 483 for Pharmalogic New York City, LLC on January 12, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharmalogic New York City, LLC
- Inspection Date: 2024-01-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Pharmalogic New York City, LLC, a PET manufacturer, revealed a significant deficiency in personnel training. The firm's on-site employees had not completed required training for the manufacture, testing, stability evaluation, and release of a specific NDA product. This indicates a serious lapse in quality system controls related to personnel qualifications.

## Related Documents

- [483 - 2026-08-19](https://www.keypedia.com/records/483/pharmalogic-new-york-city-llc/800b5cb8-e5a1-4ec6-a40b-80dc8a513ae4) — date: August 19, 2026

## Related Officers

- [Adena S. Yau](https://www.keypedia.com/people/adena-s-yau/6446432f-3882-45f4-a6a9-c62376b1724c)
- [Raihan A. Chowdhury](https://www.keypedia.com/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961