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

Source: https://www.keypedia.com/records/483/immunomedics-inc/0d82ff12-8f49-4c77-900a-98b64af491f9

> 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 Veterinary Medicine
- Summary: Immunomedics, Inc., a biologics manufacturer in Morris Plains, NJ, was cited for multiple deficiencies during an FDA inspection. Key issues included incomplete investigations into failures and complaints, inadequate documentation of QA reviews, and incomplete employee training records. Additionally, the firm failed to validate a critical test method and shipping procedures, establish specifications for chromatography column limits, and consistently follow water system monitoring SOPs.

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## 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-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4