# FDA 483 - Schering-Plough Products L.L.C. - June 05, 2001

Source: https://www.keypedia.com/records/483/schering-plough-products-llc/14a97110-6171-4b14-b206-bdd4e842d5ed

> FDA 483 for Schering-Plough Products L.L.C. on June 05, 2001. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schering-Plough Products L.L.C.
- Inspection Date: 2001-06-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: During an FDA inspection from May 1 to June 5, 2001, at Schering-Plough Products L.L.C. in Las Piedras, PR, significant deviations from regulatory requirements were observed. The company failed to follow its approved manufacturing process for K-Dur Extended Release Tablets, utilizing untested sub-batches and not ensuring content uniformity. A critical absence of validation/qualification master plans was noted, alongside incomplete corrective actions from a previous inspection concerning data maintenance and security for laboratory instruments, with raw data not being retained.

The firm's Out-of-Specification (OOS) laboratory investigation system was inadequate, characterized by re-testing without justification, unsupported conclusions for invalidating original data, and insufficient corrective actions. This included invalidating numerous OOS results based on unproven causes and continued use of malfunctioning dissolution equipment. Furthermore, manufacturing processes for Theophylline tablets, Rebetol 200mg Capsules, and Normadyne tablets were unvalidated or inadequately validated, with such products still being distributed. Process changes for Bulexin lacked proper documentation or revalidation. Laboratory analytical balances did not comply with USP standards, and essential records, including justifications for dissolution guidelines, particle size specifications, and raw data for method transfers, were unavailable or destroyed. These findings necessitate comprehensive corrective and preventive actions to ensure compliance with Good Manufacturing Practices.

## Related Officers

- [Química en CBP](https://www.keypedia.com/people/arlene-m-badillo/bf414cea-4bf7-4cae-9ac0-1f9577e4d952)
- [District Director at FDA](https://www.keypedia.com/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.keypedia.com/companies/schering-plough-products-llc/4a7b13b3-3398-4498-9198-2330c5ad7e2a

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