# FDA 483 - AbbVie Bioresearch Center - Unknown Date

Source: https://www.keypedia.com/records/483/abbvie-bioresearch-center/80e5e8eb-3991-4bd1-974d-279b0bbf2aba

> FDA 483 for AbbVie Bioresearch Center on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AbbVie Bioresearch Center
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of AbbVie Bioresearch Center in Worcester, MA, identified an issue with microbiology methods. The firm was cited for not adequately conducting these methods, specifically regarding the use of qualified inoculum or previously approved media batches for growth promotion acceptance criteria. This indicates a concern with quality control in their drug substance manufacturing processes.

## Related Documents

- [EIR - 2018-05-24](https://www.keypedia.com/records/eir/abbvie-bioresearch-center/dd106705-3ed4-4568-a1bc-df4b07029ec0)
- [EIR - 2019-11-18](https://www.keypedia.com/records/eir/abbvie-bioresearch-center/65ba65b3-8ebe-41c9-af3a-880b8c84a775)
- [483 - 2025-12-16](https://www.keypedia.com/records/483/abbvie-bioresearch-center/23610032-b531-463c-919f-799b7894969b)

## Related Officers

- [Qing Zhou PhD., Senior Staff Fellow](https://www.keypedia.com/people/qing-zhou-phd-senior-staff-fellow/18de93e1-6510-452e-b041-c4fcbca23f8b)
- [Jun Park PhD. Biologist](https://www.keypedia.com/people/jun-park-phd-biologist/6c1b59d2-d8ef-4e47-90e5-1298d7a42c94)
- [Reyes Candau-Chacon, Ph.D, Microbiologist](https://www.keypedia.com/people/reyes-candau-chacon-phd-microbiologist/7e93758f-43c6-49cb-bd5d-c240f910802d)

Company: https://www.keypedia.com/companies/abbvie-bioresearch-center/6957449c-4de8-444b-b53c-5838b33a76a1

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0