# FDA 483 - American CryoStem Corporation - May 22, 2024

Source: https://www.globalkeysolutions.net/records/483/american-cryostem-corporation/abfffeba-8f81-45c1-a04d-0d1596e796dc

> FDA 483 for American CryoStem Corporation on May 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American CryoStem Corporation
- Inspection Date: 2024-05-22
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of American CryoStem Corporation in Monmouth Junction, NJ, revealed significant deficiencies in environmental controls for aseptic processing and the use of unverified or expired supplies. These issues raise concerns about the firm's ability to prevent the introduction and spread of communicable diseases during the processing of its ATgraft HCT/P products.

## Related Documents

- [WARNING_LETTER - 2017-07-26](https://www.globalkeysolutions.net/records/warning_letter/american-cryostem-corporation/c2a4ee46-a7b5-42d5-ac7a-54b5f001f0cd)
- [483 - 2017-07-26](https://www.globalkeysolutions.net/records/483/american-cryostem-corporation/ee687377-6a85-4653-94ef-fee366e2256c)

## Related Officers

- [Michele Gottshall](https://www.globalkeysolutions.net/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)
- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.globalkeysolutions.net/companies/american-cryostem-corporation/b8fa313e-9cbe-48c1-9df3-1cebe3cb8b05

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