# FDA 483 - Hill-Rom Services Private Limited - May 10, 2018

Source: https://www.keypedia.com/records/483/hill-rom-services-private-limited/f2da0b7e-737a-4f58-97ba-bcd9ca85d763

> FDA 483 for Hill-Rom Services Private Limited on May 10, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hill-Rom Services Private Limited
- Inspection Date: 2018-05-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Hill-Rom Services Private Limited, a medical device manufacturer in Singapore, revealed two observations. The firm was cited for not adequately maintaining a device master record, specifically lacking product specifications. Additionally, records of changes were found to be deficient, as they did not include a description of a design change related to operating software.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/hill-rom-services-private-limited/a89779ff-496d-4410-b0ea-1befd2e0b608

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