# FDA 483 - PR Personal Care Laboratories - January 29, 2024

Source: https://www.keypedia.com/records/483/pr-personal-care-laboratories/1dd7fdd0-55c5-4275-b1fc-7b8d598edbdf

> FDA 483 for PR Personal Care Laboratories on January 29, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PR Personal Care Laboratories
- Inspection Date: 2024-01-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: PR Personal Care Laboratories in Valencia, CA, a Class II medical device manufacturer of personal lubricant, received three observations during an FDA inspection. The firm was cited for failing to establish procedures for complaint handling, control and disposition of nonconforming products, and adequate equipment maintenance schedules. These deficiencies indicate significant gaps in their quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/pr-personal-care-laboratories/6ce630b5-db5f-4fba-ad2b-395c95e73138

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