# FDA 483 - AGC Biologics A/S - November 05, 2019

Source: https://www.keypedia.com/records/483/agc-biologics-as/687beeb3-d308-4997-a06c-5a4cb4cc61f8

> FDA 483 for AGC Biologics A/S on November 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics A/S
- Inspection Date: 2019-11-05
- Product Type: drugs
- Office Name: Foreign - CDER (Bioresearch Monitoring)
- Summary: During an inspection conducted from October 28 to November 5, 2019, a pharmaceutical firm received an FDA Form 483 citing significant observations related to its adherence to current Good Manufacturing Practices (cGMP). Key issues included a lack of adherence to master batch records (MBRs), where unapproved manufacturing steps, such as diluting bulk material or conducting additional processing, were performed without Quality Unit approval. Procedures for allocating equipment and materials were found inadequate, leading to the use of non-approved materials and raw material delays. Batch record documentation also deviated from MBR sequences, with additional steps recorded improperly. Quality Assurance failures were noted, specifically regarding the lack of root cause investigations for 37 recurring deviations related to stability testing timelines, and the absence of corresponding corrective and preventative actions. Quality Control procedures were insufficient, with delayed approval for repeat testing impacting stability sample timelines, and stability protocols lacking proper handling instructions for drug product samples. Furthermore, documentation for assay failure investigations was inadequate, often lacking scientific justification or root cause analysis. Laboratory controls were deficient, including an inadequately validated ELISA method with a high failure rate, and an HPLC method lacking parameters for consistent data integration. Finally, batch record reviews were insufficient, as deviations from normal operating ranges were not properly documented or investigated. The firm is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with cGMP regulations.

## Related Documents

- [EIR - 2014-10-13](https://www.keypedia.com/records/eir/agc-biologics-as/7cb2f7df-9545-46bc-8ea5-00097b8f4f65)
- [EIR - 2017-11-07](https://www.keypedia.com/records/eir/agc-biologics-as/1a08a554-8116-44b5-b17e-15dcdbfd3e47)
- [483 - 2019-11-05](https://www.keypedia.com/records/483/agc-biologics-as/f86fe017-848d-474e-b2f5-bf381d2e68cd)
- [EIR - 2019-11-05](https://www.keypedia.com/records/eir/agc-biologics-as/1e663f55-fe25-484d-ba23-50e1eb369041)
- [EIR - 2019-11-05](https://www.keypedia.com/records/eir/agc-biologics-as/63869fb2-5d59-463f-9765-501061e29ee0)

## Related Officers

- [investigator](https://www.keypedia.com/people/riley-myers/22266738-1313-45db-902d-eaf4c63d4131)
- [investigator](https://www.keypedia.com/people/amy-hsu/78472f98-f37f-4534-bb3b-43f58a18266e)
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Company: https://www.keypedia.com/companies/agc-biologics-as/49ad0b3f-1a32-433e-b4e1-b6643981671c

Office: https://www.keypedia.com/offices/foreign-cder-bioresearch-monitoring/d1dedffd-4125-4ced-a8fd-dc65ee0cac8a