# FDA 483 - Munchkin Inc - October 07, 2021

Source: https://www.keypedia.com/records/483/munchkin-inc/4920ae22-5148-4ddb-be1b-f3f8cf948800

> FDA 483 for Munchkin Inc on October 07, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Munchkin Inc
- Inspection Date: 2021-10-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Munchkin, Inc. in Van Nuys, CA, a medical device manufacturer, was inspected from October 5-7, 2021. The inspection revealed a significant quality system deficiency concerning the firm's design control procedures. Specifically, the design history file for their Class II Munchkin Fun Ice Teether did not adequately demonstrate design development, review results, or design transfer.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/munchkin-inc/c388c623-f141-466f-9287-f57fe263450c

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