# FDA 483 - Limerick Inc - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/limerick-inc/99d19222-f8a2-4a36-8d1a-6025f1a02319

> FDA 483 for Limerick Inc on August 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Limerick Inc
- Inspection Date: 2025-08-15
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Limerick Inc, a medical device manufacturer in Burbank, CA, revealed three significant observations. The firm was cited for inadequate maintenance of complaint files, insufficient procedures for controlling nonconforming products, and deficiencies in establishing and maintaining device history records for Class II devices like powered breast pumps.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/limerick-inc/6d76afb9-22e3-4427-b7a9-2401b1093d8e

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b