# Cord for Life, Inc. – FDA 483, Jun 10, 2026

Source: https://www.keypedia.com/records/483/cord-for-life-inc/3428d208-1cf3-4165-a73a-1799df2610b1

> FDA 483 for Cord for Life, Inc. on June 10, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cord for Life, Inc.
- Inspection Date: 2026-06-10
- Product Type: biologics
- Office Name: Florida District Office
- Summary: Cord for Life, Inc. in Altamonte Springs, FL, received an FDA Form 483 with eight observations following an inspection from June 1-10, 2026. The inspection revealed significant deficiencies in aseptic processing, production controls, investigation procedures, record-keeping, process validation, and stability and sterility testing for their PremierMax® CB injectable products. Several observations, including issues with investigations and stability testing, were repeats from a previous inspection, indicating persistent quality system failures.

## Related Documents

- [483 - 2021-08-26](https://www.keypedia.com/records/483/cord-for-life-inc/0d9b4ab9-a499-4415-acd0-af8696ab4661) — date: August 26, 2021
- [WARNING_LETTER - 2018-11-30](https://www.keypedia.com/records/warning_letter/cord-for-life-inc/72664f21-c309-4ba3-9b10-d453c3ec07db) — date: November 30, 2018

## Related Officers

- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)
- [Abby L. Mozeke](https://www.keypedia.com/people/abby-l-mozeke/ce4ecbbc-0108-483e-aff3-d5320e50114f)

Company: https://www.keypedia.com/companies/cord-for-life-inc/61f8d186-9586-4572-bff4-ced2250d4a28

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9