# FDA 483 - Krystal Biotech, Inc. - November 16, 2022

Source: https://www.keypedia.com/records/483/krystal-biotech-inc/bc54c53c-606d-4637-b5cc-115b3eb0c9e7

> FDA 483 for Krystal Biotech, Inc. on November 16, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Krystal Biotech, Inc.
- Inspection Date: 2022-11-16
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Krystal Biotech, Inc. in Pittsburgh, PA, revealed several significant deficiencies in their manufacturing processes. Observations included a lack of quality unit review for drug product production records, failure to prevent objectionable microorganisms, and inadequate pest control leading to insect intrusion in manufacturing areas. Additionally, issues with control over incoming starting materials and drug product vials were noted, indicating a need for improved quality oversight and facility maintenance.

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## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Jianyang Wang](https://www.keypedia.com/people/jianyang-wang/92951156-d0f6-4100-b22c-ae2d03683773)
- [investigator](https://www.keypedia.com/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)
- [Bo Liang](https://www.keypedia.com/people/bo-liang/9902f822-7544-4e11-8cdc-49a99627db13)
- [Carl A. Perez](https://www.keypedia.com/people/carl-a-perez/a7214b90-7632-4aff-8afb-33f1d7e7917d)

Company: https://www.keypedia.com/companies/krystal-biotech-inc/a9722688-fbec-493a-b344-89b3fb41b9ab

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd