# FDA 483 - LNK International, Inc. - December 13, 2022

Source: https://www.globalkeysolutions.net/records/483/lnk-international-inc/b25b87dc-b743-4717-afc1-46a2b21c7c37

> FDA 483 for LNK International, Inc. on December 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LNK International, Inc.
- Inspection Date: 2022-12-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: INK International, Inc. in Hauppauge, NY, received an FDA Form 483 citing deficiencies in equipment used for drug product manufacturing and storage. The firm failed to adequately design and qualify packaging equipment for commercial batches and did not formally qualify HVAC systems in its raw material and finished product warehouses. These issues raise concerns about product quality and stability.

## 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 - 2021-07-01](https://www.globalkeysolutions.net/records/483/lnk-international-inc/0e9f6bea-0649-4076-860b-24cd601a568d)
- [483 - 2025-10-28](https://www.globalkeysolutions.net/records/483/lnk-international-inc/8d6c0d36-0344-41cc-aa15-01eb2b4e7086)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/terry-bridgewater/59dfea35-4435-47b1-ac4a-0eb6eaf83bc8)
- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

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