# FDA 483 - The Tender Corporation - September 23, 2021

Source: https://www.keypedia.com/records/483/the-tender-corporation/4be3b5d2-384e-4b60-9e37-581a15f3372e

> FDA 483 for The Tender Corporation on September 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Tender Corporation
- Inspection Date: 2021-09-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Tender Corporation received a Form 483 detailing significant deficiencies across its quality control, manufacturing, and complaint handling processes. Issues included inadequate laboratory record review, failure to follow stability testing and complaint procedures, and insufficient qualified personnel. The report also cited failures in OOS investigations, employee training, annual product reviews, and equipment cleaning and maintenance, indicating a broad lack of adherence to cGMP regulations.

## Related Documents

- [483 - 2018-10-26](https://www.keypedia.com/records/483/the-tender-corporation/c0c972dc-534f-4cba-a647-160b207c99c0)
- [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 - 2023-04-26](https://www.keypedia.com/records/483/the-tender-corporation/6f4581aa-c6a6-425a-a572-045773bd2a25)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248