# FDA 483 - LNK International, Inc. - March 07, 2017

Source: https://www.globalkeysolutions.net/records/483/lnk-international-inc/df892cf9-d930-47bd-8164-f29085dbe385

> FDA 483 for LNK International, Inc. on March 07, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LNK International, Inc.
- Inspection Date: 2017-03-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: LNK International, Inc. in Hauppauge, NY, a pharmaceutical drug manufacturer, was cited with two observations during an FDA inspection. The first observation noted a failure to prevent contamination due to uncovered empty bottles on a liquid packaging line. The second observation detailed significant issues with electronic recordkeeping, including a failure to maintain backup files and inadequate controls over computer systems and data accuracy.

## Related Documents

- [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 - 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

- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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