# FDA 483 - Tayca Corporation - December 15, 2017

Source: https://www.globalkeysolutions.net/records/483/tayca-corporation/5faaae5f-1f1b-48bc-b338-a070ad45ad48

> FDA 483 for Tayca Corporation on December 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tayca Corporation
- Inspection Date: 2017-12-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Tayca Corporation, a non-sterile API manufacturer in Okayama, Japan, was cited for significant deficiencies in its quality control unit, including inadequate investigations into out-of-specification results and communication errors, and failure to verify USP assay methods. The inspection also revealed issues with data integrity due to a lack of audit trails in analytical software, poor facility and equipment cleaning, and insufficient calibration and traceability for production equipment and materials. These observations indicate a systemic lack of robust quality management practices impacting product quality and data reliability.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/tayca-corporation/0e42c8a5-dac5-4a3e-ac69-f75748ddc0b7)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.globalkeysolutions.net/companies/tayca-corporation/46216ddd-c2d8-492b-bbc2-7011e93a98bf

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