# FDA EIR - AbbVie Inc. - December 15, 2017

Source: https://www.keypedia.com/records/eir/abbvie-inc/670afc69-446b-472a-b6de-83d020c0613a

> FDA EIR for AbbVie Inc. on December 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: AbbVie Inc.
- Inspection Date: 2017-12-15
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of AbbVie Inc.'s North Chicago, IL facility was conducted from November 27 to December 15, 2017. This was a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI), focusing on finished dosage drug manufacturing, including Imbruvica® Ibrutinib, Duopa, Humira, and Ultane (Sevoflurane). The inspection covered various systems such as quality, packaging and labeling, laboratory, facilities and equipment, materials, and production.

The inspection concluded with the issuance of a four-item FDA Form 483, detailing observations of objectionable conditions, alongside three additional discussion points for management. Key issues identified included inadequate investigation into a 24-month stability failure for fill weight in Sevoflurane, and a failure to utilize Annual Product Review feedback to address recurring "low fill" complaints for the same product proactively. Deficiencies in quality system documentation were noted, specifically the omission of historical data in complaint investigations related to serious adverse events for Humira. Furthermore, packaging operations showed weaknesses, such as a lack of standard operating procedures and documentation for in-process quality inspections, and an instance of inadequate line clearance resulting in a potential product mix-up. The firm also lacked an established schedule for periodic revalidation reviews of equipment. AbbVie Inc. is required to address these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards. Notably, the Imbruvica® Ibrutinib tablet, NDA 210563, was recommended for approval despite these findings.

## Related Documents

- [483 - 2017-12-15](https://www.keypedia.com/records/483/abbvie-inc/0596cbbe-5bd3-4926-bb9d-5e5d61b58ba4)
- [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)
- [EIR - 2021-12-15](https://www.keypedia.com/records/eir/abbvie-inc/4ea67f2c-2701-4a6c-b4a3-6225b781f7a3)

## Related Officers

- [company_representative](https://www.keypedia.com/people/chad-ballard/27b6f31e-3b1d-468e-936d-fc531e8d3bf4)
- [company_representative](https://www.keypedia.com/people/scott-page/33111b5b-0fb4-4def-b3b2-2fe5e22a9168)
- [company_representative](https://www.keypedia.com/people/walter-routh/38e9c62b-42fa-42a9-80b0-4c12c2ff024f)
- [Investigator](https://www.keypedia.com/people/russell-k-riley/4813d9c2-52a3-4eba-8606-d4be5e03fd04)
- [Amy A. Johnson](https://www.keypedia.com/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

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