# FDA 483 - Celltex Therapeutics Corporation - April 27, 2012

Source: https://www.keypedia.com/records/483/celltex-therapeutics-corporation/86c87d39-1d07-4f07-b209-6dae485136d5

> FDA 483 for Celltex Therapeutics Corporation on April 27, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltex Therapeutics Corporation
- Inspection Date: 2012-04-27
- Office Name: Dallas District Office
- Summary: An FDA inspection conducted from April 16 to April 27, 2012, at Celltex Therapeutics Corporation in Sugarland, TX, a biological drug manufacturer, revealed significant deviations from regulatory requirements. The observations primarily concerned the manufacturing of mesenchymal stem cells (MSCs) intended for patient administration. Key violations included a systemic lack of process validation for MSC production, failing to ensure batch uniformity, integrity, and sterility. Specifically, Celltex did not validate critical manufacturing steps, aseptic gowning procedures, or the banking and thawing processes. Sterility test failures were noted without proper investigation or destruction records for affected batches. Environmental monitoring was inadequate, with microbial isolations exceeding specifications and no identification or investigation. Furthermore, the company failed to maintain comprehensive documentation, including batch production and control records, equipment calibration logs, and records for the receipt and disposition of critical supplies and reagents. Many reagents used were labeled "FOR RESEARCH USE ONLY," indicating they were not suitable for human therapeutic use. Quality control unit reviews of manufacturing records were incomplete prior to product release. Equipment like centrifuges was inappropriately operated on the floor, and product labels lacked essential information like sterility status, strength, and biohazard warnings. Basic facility deficiencies included the absence of a hand washing facility in the cleanroom area, posing contamination risks. These observations highlight a need for Celltex Therapeutics Corporation to implement robust corrective and preventive actions to ensure compliance with good manufacturing practices and safeguard product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2012-04-27](https://www.keypedia.com/records/warning_letter/celltex-therapeutics-corporation/f06f5521-e0fd-437f-b732-bffb4da007b3)

## Related Officers

- [Investigator](https://www.keypedia.com/people/joel-martinez/c83d1413-732e-4d56-b4d1-672705413a18)

Company: https://www.keypedia.com/companies/celltex-therapeutics-corporation/74a0e909-b729-43a2-a75b-5878dda5f179

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9