# FDA 483 - KDL Precision Molding - February 07, 2019

Source: https://www.globalkeysolutions.net/records/483/kdl-precision-molding/ee3f5045-5e4f-4a9e-80dd-2bc7814aa02b

> FDA 483 for KDL Precision Molding on February 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KDL Precision Molding
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of RDI Precision Molding in Pacoima, CA, a Class II & III medical device manufacturer, identified two significant observations. The firm failed to review, evaluate, and revalidate a process when changes occurred, specifically regarding the use of an unvalidated liquid injection molding machine for FemCap devices. Additionally, the company lacked established procedures to control labeling activities for its FemCap and (b)(4) devices, leading to undocumented labeling inspections and missing primary identification labels in Device History Records.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/kdl-precision-molding/0c8495fe-9363-4065-8737-0bda13b09dae

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6