# FDA 483 - Tenderneeds Fertility LLC - September 29, 2021

Source: https://www.globalkeysolutions.net/records/483/tenderneeds-fertility-llc/e68fa6ed-a506-405e-995c-6e57f075cc98

> FDA 483 for Tenderneeds Fertility LLC on September 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tenderneeds Fertility LLC
- Inspection Date: 2021-09-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Tenderneeds Fertility LLC in Greenville, IN, was inspected by the FDA, resulting in seven observations highlighting a severe lack of fundamental quality system procedures. The firm failed to establish and maintain procedures for design control, complaint handling, design history files, MDRs, purchase control, nonconforming product, and corrective and preventive actions. Many of these deficiencies were noted as repeat observations, indicating systemic issues in meeting regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2019-12-13](https://www.globalkeysolutions.net/records/483/tenderneeds-fertility-llc/6d9aa84a-17b9-4a23-8160-7616868b5fb4)
- [WARNING_LETTER - 2019-12-13](https://www.globalkeysolutions.net/records/warning_letter/tenderneeds-fertility-llc/cfc6a941-4228-4ab4-8a58-6cd506827aaf)

## Related Officers

- [Lee Terry Moore](https://www.globalkeysolutions.net/people/lee-terry-moore/eed5f225-7c3d-467a-8efb-7bb2e809c6b6)
- [Talmane J. Fisher](https://www.globalkeysolutions.net/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.globalkeysolutions.net/companies/tenderneeds-fertility-llc/90e98041-7744-45c1-9955-b97421665cc2

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0