# FDA 483 - The Tender Corporation - October 26, 2018

Source: https://www.keypedia.com/records/483/the-tender-corporation/c0c972dc-534f-4cba-a647-160b207c99c0

> FDA 483 for The Tender Corporation on October 26, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Tender Corporation
- Inspection Date: 2018-10-26
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: The FDA inspected Tender Corporation, a manufacturer, and issued a Form 483 citing two observations. The firm failed to establish procedures for corrective and preventive actions, specifically regarding the analysis of deviations and complaints. Additionally, complaint files were not adequately maintained, lacking proper documentation for uninvestigated complaints or thorough review of potential device or package failures.

## Related Documents

- [483 - 2019-11-25](https://www.keypedia.com/records/483/the-tender-corporation/70dd7c43-1917-4460-9ff6-9c27bdadf7f0)
- [WARNING_LETTER - 2019-11-25](https://www.keypedia.com/records/warning_letter/the-tender-corporation/d99c6422-278a-4ad1-ad25-d073adec6493)
- [483 - 2021-09-23](https://www.keypedia.com/records/483/the-tender-corporation/4be3b5d2-384e-4b60-9e37-581a15f3372e)
- [483 - 2023-04-26](https://www.keypedia.com/records/483/the-tender-corporation/6f4581aa-c6a6-425a-a572-045773bd2a25)

## Related Officers

- [Business Owner](https://www.keypedia.com/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)

Company: https://www.keypedia.com/companies/the-tender-corporation/86a7c0de-a5cf-4f80-96fe-eceed91a4c5e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94