# FDA 483 - ITL Asia Pacific Sdn Bhd - May 30, 2019

Source: https://www.keypedia.com/records/483/itl-asia-pacific-sdn-bhd/2c2250bf-e735-4520-8eba-9ed9209f7858

> FDA 483 for ITL Asia Pacific Sdn Bhd on May 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITL Asia Pacific Sdn Bhd
- Inspection Date: 2019-05-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ITL Asia Pacific Sdn Bhd, a medical device manufacturer in Batu Gajah, Malaysia, was inspected and cited for significant quality system deficiencies. The inspection revealed failures in establishing and following procedures for design control, corrective and preventive actions, process validation, device history records, complaint handling, medical device reporting, and quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality processes for their SampLok Luer Kit and SampLok System with Hinged Lid.

## Related Documents

- [WARNING_LETTER - 2019-05-30](https://www.keypedia.com/records/warning_letter/itl-asia-pacific-sdn-bhd/4e5b68fb-7892-4d56-be4f-0ba204bdd7c4)

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/itl-asia-pacific-sdn-bhd/2ee0589d-a696-4438-b0b2-6202d3b921a1

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