# FDA 483 - The Tender Corporation - April 26, 2023

Source: https://www.globalkeysolutions.net/records/483/the-tender-corporation/6f4581aa-c6a6-425a-a572-045773bd2a25

> FDA 483 for The Tender Corporation on April 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Tender Corporation
- Inspection Date: 2023-04-26
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: The FDA inspected The Tender Corporation in Littleton, NH, and issued a Form 483 with four observations. The inspection revealed significant deficiencies in component identity testing, API sampling procedures, adherence to production and process control procedures, and controls over computer systems used for GMP activities. These issues indicate a lack of robust quality control and data integrity practices at the manufacturing facility.

## Related Documents

- [483 - 2018-10-26](https://www.globalkeysolutions.net/records/483/the-tender-corporation/c0c972dc-534f-4cba-a647-160b207c99c0)
- [483 - 2019-11-25](https://www.globalkeysolutions.net/records/483/the-tender-corporation/70dd7c43-1917-4460-9ff6-9c27bdadf7f0)
- [WARNING_LETTER - 2019-11-25](https://www.globalkeysolutions.net/records/warning_letter/the-tender-corporation/d99c6422-278a-4ad1-ad25-d073adec6493)
- [483 - 2021-09-23](https://www.globalkeysolutions.net/records/483/the-tender-corporation/4be3b5d2-384e-4b60-9e37-581a15f3372e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7