# FDA 483 - AbbVie Inc. - January 31, 2023

Source: https://www.keypedia.com/records/483/abbvie-inc/51b48e1e-9723-4387-b252-4cc5015026fd

> FDA 483 for AbbVie Inc. on January 31, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AbbVie Inc.
- Inspection Date: 2023-01-31
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Abbvie, Inc. in North Chicago, IL was inspected and received a Form 483 with five observations. The inspection revealed significant issues with laboratory controls, including inadequate investigations into OOS/OOT results and untimely confirmatory testing using expired samples. Additionally, the firm failed to establish scientifically sound specifications, maintain proper quality control unit responsibilities, control cross-contamination, and follow written procedures for equipment cleaning and maintenance.

## Related Documents

- [483 - 2017-12-15](https://www.keypedia.com/records/483/abbvie-inc/0596cbbe-5bd3-4926-bb9d-5e5d61b58ba4)
- [EIR - 2017-12-15](https://www.keypedia.com/records/eir/abbvie-inc/670afc69-446b-472a-b6de-83d020c0613a)
- [483 - 2018-07-02](https://www.keypedia.com/records/483/abbvie-inc/3b96cb46-4514-4018-a787-d89fad0a8d6f)
- [EIR - 2018-07-02](https://www.keypedia.com/records/eir/abbvie-inc/d5fd9956-7bc9-426d-8892-df6415f4b92b)
- [EIR - 2019-02-15](https://www.keypedia.com/records/eir/abbvie-inc/e854b1d5-8667-473b-aea4-d77c030613dc)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/abbvie-inc/e9d2de86-ad64-4278-8fb3-a8cd7909719e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669