# FDA 483 - Almitech, Inc. - March 30, 2018

Source: https://www.globalkeysolutions.net/records/483/almitech-inc/5f5ff164-b44c-431a-852b-132ac0aea0a0

> FDA 483 for Almitech, Inc. on March 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Almitech, Inc.
- Inspection Date: 2018-03-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Almitech, Inc. in Bellmore, NY, a manufacturer of dental implant systems, was inspected by the FDA. The inspection revealed significant deficiencies in design and process validation documentation, including a lack of shelf stability data for sterile dental implants and unapproved sterilization and sealing processes. Additionally, the firm failed to establish procedures for receiving and evaluating customer complaints.

## Related Officers

- [Jacqueline S. Warner](https://www.globalkeysolutions.net/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.globalkeysolutions.net/companies/almitech-inc/5e6d505b-7c09-4211-bc95-38b86da5a31f

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