# FDA 483 - LNK International, Inc. - February 08, 2019

Source: https://www.globalkeysolutions.net/records/483/lnk-international-inc/498a2eef-e64f-468b-9ece-7cdf978b5fb6

> FDA 483 for LNK International, Inc. on February 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LNK International, Inc.
- Inspection Date: 2019-02-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: LNK International, Inc., an OTC drug manufacturer in Hauppauge, NY, received a Form 483 with three observations. The firm failed to thoroughly investigate out-of-specification microbial counts for a syrup product, leading to its release. Additionally, complaint investigation records were incomplete, and laboratory controls lacked appropriate testing procedures for impurities and dissolution for several combination drug products.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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