# FDA 483 - LNK International, Inc. - July 01, 2021

Source: https://www.globalkeysolutions.net/records/483/lnk-international-inc/0e9f6bea-0649-4076-860b-24cd601a568d

> FDA 483 for LNK International, Inc. on July 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LNK International, Inc.
- Inspection Date: 2021-07-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: LNK International, Inc. in Hauppauge, NY, was inspected by the FDA, resulting in five observations related to manufacturing and quality control deficiencies. Issues included inadequate equipment cleaning, failures in quality control unit procedures and process validation, non-compliance with complaint handling, insufficient laboratory controls for solution stability, and lack of proper employee training regarding GMP documentation. These observations indicate significant concerns with the firm's adherence to current good manufacturing practices.

## Related Documents

- [483 - 2017-03-07](https://www.globalkeysolutions.net/records/483/lnk-international-inc/df892cf9-d930-47bd-8164-f29085dbe385)
- [483 - 2019-02-08](https://www.globalkeysolutions.net/records/483/lnk-international-inc/498a2eef-e64f-468b-9ece-7cdf978b5fb6)
- [WARNING_LETTER - 2019-02-08](https://www.globalkeysolutions.net/records/warning_letter/lnk-international-inc/728fa12b-072c-4c33-948e-9f9cbfa13eec)
- [483 - 2022-12-13](https://www.globalkeysolutions.net/records/483/lnk-international-inc/b25b87dc-b743-4717-afc1-46a2b21c7c37)
- [483 - 2025-10-28](https://www.globalkeysolutions.net/records/483/lnk-international-inc/8d6c0d36-0344-41cc-aa15-01eb2b4e7086)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Director of Investigations Branch](https://www.globalkeysolutions.net/people/nerizza-guerin/407df995-bd23-4948-82c2-e3bf8a6659b7)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [Juan R. Jimenez Garcia](https://www.globalkeysolutions.net/people/juan-r-jimenez-garcia/c0f9553c-9060-4512-b51e-792d2dccacfe)

Company: https://www.globalkeysolutions.net/companies/lnk-international-inc/69c2d233-3b10-4e6e-8b0d-c9ac1a38d4c4

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