# FDA 483 - American CryoStem Corporation - July 26, 2017

Source: https://www.keypedia.com/records/483/american-cryostem-corporation/ee687377-6a85-4653-94ef-fee366e2256c

> FDA 483 for American CryoStem Corporation on July 26, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American CryoStem Corporation
- Inspection Date: 2017-07-26
- Product Type: Devices
- Office Name: Florida District Office
- Summary: This FDA Form 483 details observations from an inspection of a facility manufacturing stromal vascular fraction (SVF) and ATCell expanded mesenchymal stem cells (MSCs) biological drug products, with approximately (b)(4) batches of ATCell distributed since 2011.

Key violations include:
1.  **Lack of Sterilization Process Validation:** Procedures to prevent microbiological contamination of sterile drug products do not include validation of aseptic processes for SVF isolation and MSC expansion.
2.  **Absence of Process Validation:** No written procedures for production and process controls ensure drug product identity, strength, quality, and purity, as manufacturing processes for SVF and ATCell have not been validated.
3.  **Deficient Environmental Monitoring:** A program for environmental monitoring for microorganisms in aseptic processing areas has not been established since operations began in 2011.
4.  **Inadequate Component Supplier Reliability Validation:** Reliability of component suppliers' analyses (e.g., for (b)(4) and (b)(4)) is deficient, lacking at least one specific identity test and appropriate validation of supplier test results.
5.  **Missing Component Sampling and Testing Procedures:** No written procedures exist for sampling and testing upon receipt of manufacturing components like (b)(4) and (b)(4).
6.  **No Drug Product Stability Testing Program:** A written program to assess drug product stability characteristics is absent.
7.  **Unvalidated Cleaning

## Related Documents

- [WARNING_LETTER - 2017-07-26](https://www.keypedia.com/records/warning_letter/american-cryostem-corporation/c2a4ee46-a7b5-42d5-ac7a-54b5f001f0cd)
- [483 - 2024-05-22](https://www.keypedia.com/records/483/american-cryostem-corporation/abfffeba-8f81-45c1-a04d-0d1596e796dc)

## Related Officers

- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)
- [Consumer Safety](https://www.keypedia.com/people/kip-j-hanks/839cb755-ff60-448c-9b21-b84b78b59a15)

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

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