# FDA 483 - LS Promotions Inc. - May 02, 2024

Source: https://www.globalkeysolutions.net/records/483/ls-promotions-inc/f546b58c-2290-43d7-a6e7-a16eacf82719

> FDA 483 for LS Promotions Inc. on May 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LS Promotions Inc.
- Inspection Date: 2024-05-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: LS Promotions Inc., a human drug repackager and relabeler in Ronkonkoma, NY, was cited for numerous significant cGMP violations during an FDA inspection. The firm demonstrated a severe lack of quality control oversight, inadequate written procedures for production, process controls, and equipment management, and failed to ensure proper storage, stability testing, and component identity verification for its drug products, including sunscreens, hand sanitizers, and lip balms. These deficiencies indicate a systemic failure to maintain drug product quality, identity, strength, and purity.

## Related Documents

- [WARNING_LETTER - 2024-05-02](https://www.globalkeysolutions.net/records/warning_letter/ls-promotions-inc/f84015c6-73cf-4dd6-b2e5-0daedcd35350)

## Related Officers

- [Amatul H. Marium](https://www.globalkeysolutions.net/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)
- [Adena S. Yau](https://www.globalkeysolutions.net/people/adena-s-yau/6446432f-3882-45f4-a6a9-c62376b1724c)
- [Raihan A. Chowdhury](https://www.globalkeysolutions.net/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)

Company: https://www.globalkeysolutions.net/companies/ls-promotions-inc/9825ac21-f1b0-4b9d-8a4a-ceaf3b5848f6

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