# FDA 483 - Novacyl (Thailand) Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/novacyl-thailand-ltd/467e30d6-b74a-447d-9c6f-e37fdf6c825e

> FDA 483 for Novacyl (Thailand) Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novacyl (Thailand) Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Novacyl (Thailand) Ltd., a manufacturer, was inspected by the FDA, revealing significant deficiencies in its Quality Unit's handling of complaint investigations. The firm failed to extend investigations to potentially affected batches and did not complete complaint investigation forms within required timelines, indicating a lapse in quality management. These issues suggest a need for improved adherence to internal procedures and comprehensive quality oversight.

## Related Documents

- [WARNING_LETTER - 2014-04-25](https://www.keypedia.com/records/warning_letter/novacyl-thailand-ltd/a06c90bf-0ce1-4f90-b7f3-a357a7cf2d70)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.keypedia.com/companies/novacyl-thailand-ltd/a3ab6219-74d7-42bc-a5b7-c5ad487f81dd

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd