# FDA 483 - Immunomedics, Inc. - January 23, 2003

Source: https://www.keypedia.com/records/483/immunomedics-inc/6366a984-045f-4a07-aa45-88b924fbb979

> FDA 483 for Immunomedics, Inc. on January 23, 2003. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunomedics, Inc.
- Inspection Date: 2003-01-23
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: An FDA Form 483 was issued to Immunomedics, Inc., a biologics manufacturer located in Morris Plains, NJ, following an inspection conducted from January 14-17 and 23, 2003. The document details seven significant observations indicating deficiencies in the firm's quality management systems and adherence to good manufacturing practices. Key issues highlighted include the incomplete or uninitiated investigations into product failures, customer complaints, and process deviations. For instance, reports of a failed QC test, a sterility failure, and product breakage during shipment lacked thorough investigation, root cause identification, or verification of corrective actions.The inspection also found that Quality Assurance review of analytical results was not consistently documented, and training records for manufacturing personnel were incomplete, particularly regarding recent process changes. Critical manufacturing and testing aspects were also deficient; an in-house Loss-On-Drying test method was unvalidated, and there were no established specifications for endotoxin or bioburden in cleaned chromatography columns—a repeat observation. Furthermore, shipping procedures lacked validation to ensure proper temperature control for both bulk and finished products during transit. Finally, the firm did not consistently adhere to its own Standard Operating Procedure for the Deionized Water System, failing to implement specified corrective actions for resistivity failures.These observations require Immunomedics, Inc. to provide a comprehensive response detailing the corrective and preventive actions to achieve compliance with regulatory expectations for biologics manufacturing.

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- [483 - 2003-01-23](https://www.keypedia.com/records/483/immunomedics-inc/0d82ff12-8f49-4c77-900a-98b64af491f9)

## Related Officers

- [Deputy Director](https://www.keypedia.com/people/ann-marie-montemurro/bb7189b4-88c2-4375-acaf-804a5d98a26d)

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

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d