# FDA 483 - Tecomet, Inc. - May 07, 2019

Source: https://www.keypedia.com/records/483/tecomet-inc/f7334355-5af2-471a-86e3-a52c3f8a1db1

> FDA 483 for Tecomet, Inc. on May 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tecomet, Inc.
- Inspection Date: 2019-05-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Tecoset, Inc., a contract manufacturer in Hillburn, NY, conducted from May 2-7, 2019, identified one significant observation. The firm's procedures for training and identifying employee training needs were found to be inadequately established. This indicates a deficiency in their quality system regarding personnel training.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)
- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/tecomet-inc/c00229cb-b05f-414b-bd9b-93bc169dc8d2

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