# FDA 483 - The Tender Corporation - November 25, 2019

Source: https://www.globalkeysolutions.net/records/483/the-tender-corporation/70dd7c43-1917-4460-9ff6-9c27bdadf7f0

> FDA 483 for The Tender Corporation on November 25, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The Tender Corporation
- Inspection Date: 2019-11-25
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Tender Corporation in Littleton, NH, revealed significant deficiencies in laboratory controls, record-keeping, and quality unit procedures for their OTC drug products, particularly After Bite. Repeated observations regarding inadequate specifications for ammonia content and widespread data integrity issues were noted, indicating a systemic failure to ensure product quality and compliance. The firm also failed to thoroughly investigate out-of-specification events and maintain complete batch production records.

## Related Documents

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

## Related Officers

- [Regional Manager](https://www.globalkeysolutions.net/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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