# FDA 483 - Immunomedics, Inc. - March 10, 2020

Source: https://www.keypedia.com/records/483/immunomedics-inc/977f14da-5f9b-480a-9034-95991b8ebabc

> FDA 483 for Immunomedics, Inc. on March 10, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunomedics, Inc.
- Inspection Date: 2020-03-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On March 10, 2020, the FDA issued a Form 483 to Immunomedics, Inc., a drug substance intermediate manufacturer located in Morris Plains, NJ, following an inspection from March 2-10, 2020. The inspection revealed ten observations related to quality system and manufacturing deficiencies.

Key observations include:
1.  **Microbiological Contamination Control:** Procedures and controls to prevent microbiological contamination of drug substance intermediates are not established. This includes a lack of procedures, gowning requirements, and QA review for dynamic smoke studies in ISO 5 Biological Safety Cabinets (BSCs), with studies not simulating worst-case conditions. Additionally, a filter used for sterilization is not routinely sterilized or integrity tested, and the water used for sterilization is not routinely tested for critical physical qualities.
2.  **Quality Control Unit Responsibilities:** The responsibilities and procedures of the quality control unit are not fully followed. Final QA and microbiology review and approval for operations were not performed in a timely manner, leading to conditional approvals and ongoing production without complete release. Bare hands, bare forearms, and street clothes were observed within a BSC during dynamic smoke studies, and associated medium bottles were subsequently used without QA or microbiology evaluation. Chromatograms are not electronically or manually indicated for quality unit review.
3.  **Inadequate/Unfollowed SOPs:** Standard Operating Procedures (SOPs) are inadequate or not followed. Examples include:

## Related Documents

- [483 - 2003-01-23](https://www.keypedia.com/records/483/immunomedics-inc/6366a984-045f-4a07-aa45-88b924fbb979)
- [483 - Unknown Date](https://www.keypedia.com/records/483/immunomedics-inc/38181c37-8c5a-4d62-b05f-61df7091f848)
- [483 - 2020-03-10](https://www.keypedia.com/records/483/immunomedics-inc/ed86ff8e-c9e9-48d9-a91b-aa7a531d5c87)
- [483 - 2018-08-14](https://www.keypedia.com/records/483/immunomedics-inc/6cd1946a-c9b5-4076-8fc0-9ca5c7959ca2)
- [483 - 2003-01-23](https://www.keypedia.com/records/483/immunomedics-inc/0d82ff12-8f49-4c77-900a-98b64af491f9)

## Related Officers

- [Andrea Siegel](https://www.keypedia.com/people/andrea-siegel/7436ec58-8c64-4ad9-a6cf-7c2039c51447)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Willie Wilson](https://www.keypedia.com/people/willie-wilson/d7028341-a417-41c9-ac00-997bfda722bb)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/immunomedics-inc/2741160b-58d0-47a4-abc6-1151bd4c6bfa

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c