# FDA 483 - Handicare Accessibility, Ltd. - February 07, 2019

Source: https://www.keypedia.com/records/483/handicare-accessibility-ltd/51f55771-d429-483c-9546-8a0a63ab1d79

> FDA 483 for Handicare Accessibility, Ltd. on February 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Handicare Accessibility, Ltd.
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Handicare Accessibility, Ltd., a foreign medical device manufacturer of powered stairway chair lifts, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for complaint handling and corrective and preventive actions, leading to hundreds of uninvestigated complaints and retrospective CAPA documentation. Additionally, the company did not conduct scheduled internal quality audits and submitted Medical Device Reports beyond the required 30-day timeframe.

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/handicare-accessibility-ltd/31b1562a-e5fa-4741-8bc9-9eac4ff726c9

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