# FDA EIR - Schering-Plough Ltd - June 20, 1997

Source: https://www.keypedia.com/records/eir/schering-plough-ltd/7de70b8c-e283-4f12-938c-2c944debefe0

> FDA EIR for Schering-Plough Ltd on June 20, 1997. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Schering-Plough Ltd
- Inspection Date: 1997-06-20
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: An FDA pre-approval inspection of Schering Plough's Kenilworth, NJ facility was conducted from June 9-20, 1997, under Program 7346.832, focusing on a supplement to an existing product, Gentamicin Sulfate Soluble Powder. The inspection revealed several significant deficiencies primarily concerning quality control and validation processes. Main issues documented on an FDA-483 included: inadequate qualification of the Process Control Computer used for manufacturing, with observed temperature and RPM deviations lacking investigation; a lack of proper documentation and investigation into reported color changes observed in multiple batches during stability studies, inadequately attributed to "analyst variation"; and failure to investigate high counts of Pseudomonas cepacia found during water system validation, which exceeded established microbiological guidelines. An FDA-483, List of Inspectional Observations, was issued to management, who committed to implementing all necessary corrections and providing a written response. Due to incomplete validation at the time of inspection, a withhold recommendation was submitted, necessitating a follow-up inspection to verify the corrective actions and validation batches.

## Related Documents

- [EIR - 1997-06-20](https://www.keypedia.com/records/eir/schering-plough-ltd/48265bf4-6af9-4365-937c-9edc51a96a66)

## Related Officers

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- [company_representative](https://www.keypedia.com/people/joel-sequeira/187c305c-c2d5-48d1-afcf-dea55da7ab01)
- [company_representative](https://www.keypedia.com/people/richard-taborell/1fcab11f-c4c6-4843-8e5b-96f36098d48d)
- [investigator](https://www.keypedia.com/people/amy-josephson/24aef0c8-0d20-44f1-ae44-55e43c840038)
- [company_representative](https://www.keypedia.com/people/joseph-pavelchak/38dbc864-9dac-4d65-877d-3d0ff2484da4)

Company: https://www.keypedia.com/companies/schering-plough-ltd/10bba741-bbd7-46e2-bab9-ecc3f9851364

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248