# FDA 483 - ImClone Systems, LLC - July 27, 2023

Source: https://www.keypedia.com/records/483/imclone-systems-llc/aca06d28-b62d-453e-a6cb-32610eccbc46

> FDA 483 for ImClone Systems, LLC on July 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImClone Systems, LLC
- Inspection Date: 2023-07-27
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During inspections conducted between July 10-14, July 20-21, and July 27, 2023, the U.S. Food and Drug Administration issued a Form 483 to ImClone Systems LLC, a drug substance manufacturer located in Branchburg, NJ. The document outlines eight significant observations, indicating areas where the company's operations did not meet regulatory expectations for Good Manufacturing Practices.

Key issues identified include inadequate management of Quality Control (QC) samples, evidenced by missing reference standards, stability samples, and QC release samples, as well as failures to accurately track sample movements and disposals in the Laboratory Information Management System (LIMS). The inspection also revealed deficiencies in the management of computerized systems, with routine analysts possessing excessive user access privileges and a lack of defined procedures for access levels.

Furthermore, investigations into out-of-specification results and unexplained discrepancies were found to lack thorough root cause analyses and scientific justification for subsequent testing. ImClone Systems LLC was also cited for inadequate oversight of personnel training, with numerous instances of staff performing critical GMP activities without required training. Material receipt and inspection processes were found to be deficient, specifically regarding the visual inspection of final container closure systems and insufficient criteria for rejecting compromised incoming materials.

Other observations noted inadequate calibration intervals for manufacturing systems, potentially compromising instrument accuracy, and a lack of proper maintenance for facilities and equipment, including issues with purification vessels, deteriorated insulation, and an uncalibrated biosafety cabinet component. Finally, a laboratory procedure for personnel environmental monitoring was not correctly followed. ImClone Systems LLC is expected to provide a comprehensive response detailing corrective and preventive actions to address these observations.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/ae1b1bac-061f-4570-b184-9b382ec3c67f)
- [483 - 2020-08-21](https://www.keypedia.com/records/483/imclone-systems-llc/db44c46a-32b3-4767-929a-56d701d813ae)
- [483 - 2019-11-26](https://www.keypedia.com/records/483/imclone-systems-llc/47cd6878-6a5e-4876-9ce7-aee2c4c2cbc1)
- [EIR - 2015-07-10](https://www.keypedia.com/records/eir/imclone-systems-llc/783c5945-39b5-4aa5-a271-b36bbe7e834d)
- [483 - 2020-08-21](https://www.keypedia.com/records/483/imclone-systems-llc/17887304-654e-4236-96ff-77b26cdf4296)

## Related Officers

- [Aditi S. Thakur](https://www.keypedia.com/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Samuel Mindaye, Lead Interdisciplinary Scientist](https://www.keypedia.com/people/samuel-mindaye-lead-interdisciplinary-scientist/2f50f059-06b1-49cf-a19f-05f7fec4e107)
- [Yuan-Chia Kuo](https://www.keypedia.com/people/yuan-chia-kuo/35ef21f6-5de8-4fc7-a319-5d5666a4fb62)
- [issuing_officer](https://www.keypedia.com/people/charles-y-kuo/36d44416-c980-4b33-b62e-ea0761a46a46)

Company: https://www.keypedia.com/companies/imclone-systems-llc/ccde4edf-e0cb-4367-a935-725ce0bad4d3

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa