# FDA 483 - Candela Corporation - January 24, 2023

Source: https://www.keypedia.com/records/483/candela-corporation/c1442718-a58f-4e37-b31e-3bec909113ad

> FDA 483 for Candela Corporation on January 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Candela Corporation
- Inspection Date: 2023-01-24
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Candela Corporation, a medical device manufacturer in Marlborough, MA, was inspected and cited for significant issues across three observations. The inspection revealed inadequacies in complaint file maintenance, a failure to submit a required Medical Device Report (MDR) for a malfunctioning laser, and poorly maintained device history records with illegible safety labeling. These findings indicate a moderate level of severity regarding quality system compliance.

## Related Officers

- [Guozhou Mo](https://www.keypedia.com/people/guozhou-mo/5b8f68f4-51f2-4031-9a63-5ea5713109e6)
- [Kayla R. Huffman](https://www.keypedia.com/people/kayla-r-huffman/86044a8a-5f35-43de-a293-05563c7cf891)
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Company: https://www.keypedia.com/companies/candela-corporation/fe3bb12c-8e46-4540-9811-9209524de3c6

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94