# FDA 483 - uniQure, Inc. - August 15, 2022

Source: https://www.globalkeysolutions.net/records/483/uniqure-inc/adcb7efd-e555-4556-974f-ca3d98277822

> FDA 483 for uniQure, Inc. on August 15, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: uniQure, Inc.
- Inspection Date: 2022-08-15
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: uniQure, Inc. in Lexington, MA, a Biological Contract Manufacturing Organization, was cited with three observations during an FDA inspection. The observations highlight significant deficiencies in preventing microbiological contamination during sterile drug product manufacturing, a lack of effective QA oversight for deviation investigations, and failures to follow written procedures for the storage and rejection of components, including expired materials.

## Related Officers

- [Umee Ranjan, Investigator](https://www.globalkeysolutions.net/people/umee-ranjan-investigator/edf3f1ec-85e8-4513-9901-4a397046cc85)
- [Carly E. Clay, Ph.D., Biologist](https://www.globalkeysolutions.net/people/carly-e-clay-phd-biologist/d0a0d5e8-e3ee-46d9-8108-df6c0b942c96)
- [Anurag Sharma, Ph.D., Staff Fellow](https://www.globalkeysolutions.net/people/anurag-sharma-phd-staff-fellow/0852e654-80ac-4d83-a925-ee3841ea930a)
- [Candido D. T. de los Reyes, Jr., CSO](https://www.globalkeysolutions.net/people/candido-d-t-de-los-reyes-jr-cso/4b7d1f79-8f35-4bd6-bedd-4443b982c9bf)

Company: https://www.globalkeysolutions.net/companies/uniqure-inc/7a7de435-1da5-4893-a275-9240daaedf2c

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