# FDA 483 - Nulatex Sdn. Bhd. - October 19, 2023

Source: https://www.keypedia.com/records/483/nulatex-sdn-bhd/2bb33035-beee-4150-bbc2-84dc3ad036b7

> FDA 483 for Nulatex Sdn. Bhd. on October 19, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nulatex Sdn. Bhd.
- Inspection Date: 2023-10-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Nulatex Sdn. Bhd. in Kluang, Malaysia, a manufacturer of latex products, was cited by the FDA for significant deficiencies in its quality system. The inspection revealed inadequate procedures for complaint handling, corrective and preventive actions (CAPA), and the control of in-process products. These issues indicate a lack of robust processes and proper documentation, potentially impacting product quality and safety.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/nulatex-sdn-bhd/a3cd42f6-0389-4380-bcb6-db79f0eef681

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