# FDA 483 - Celularity Inc - August 22, 2023

Source: https://www.globalkeysolutions.net/records/483/celularity-inc/baa0c20c-649c-4463-84ab-bc6941324c5a

> FDA 483 for Celularity Inc on August 22, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celularity Inc
- Inspection Date: 2023-08-22
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: Celularity Inc. in Florham Park, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing processes for human placental connective tissue matrix products (Interfyl) and decellularized, dehydrated human placenta tissue matrix products (CentaFlex). The inspection revealed failures in process validation, final product testing, component control, expiration date determination, stability testing for reconstitution, in-process material testing, and labeling control. These issues indicate a lack of adequate controls to assure drug product identity, strength, purity, and quality.

## Related Documents

- [WARNING_LETTER - 2023-08-22](https://www.globalkeysolutions.net/records/warning_letter/celularity-inc/c5529900-036f-43f5-8e21-9b14d76aafb3)

## Related Officers

- [Supervisory](https://www.globalkeysolutions.net/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)
- [Cody D. Rickman](https://www.globalkeysolutions.net/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)
- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.globalkeysolutions.net/companies/celularity-inc/0a378fd8-7c8c-4c83-8824-31c652745221

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