# FDA 483 - HOYA LAMPHUN LTD - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/hoya-lamphun-ltd/47f4f2c7-a148-4964-8d65-3b9cfdcbab19

> FDA 483 for HOYA LAMPHUN LTD on April 06, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: HOYA LAMPHUN LTD
- Inspection Date: 2023-04-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: HOYA LAMPHUN LTD, a medical device manufacturer in Lamphun, Thailand, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate establishment and implementation of corrective and preventive action procedures and data analysis procedures. Additionally, the firm failed to adequately validate processes for its iSert brand IOL devices.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/hoya-lamphun-ltd/2e733a73-7164-4d9f-b593-5556703d6fe3

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