# FDA 483 - Gram Laboratories Inc - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/gram-laboratories-inc/79f9c587-ce7a-4b46-8471-e6bfdd9106c4

> FDA 483 for Gram Laboratories Inc on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gram Laboratories Inc
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Gram Laboratories Inc, a contract testing laboratory in Irvine, CA, was cited for three observations during an FDA inspection from April 2-8, 2025. The inspection revealed deficiencies including inadequate investigations into system suitability failures, unqualified equipment and insufficient monitoring of water systems, and a lack of required cGMP training for employees. These issues indicate potential risks to data integrity and product quality.

## Related Documents

- [483 - 2015-09-04](https://www.globalkeysolutions.net/records/483/gram-laboratories-inc/5581dd6f-53f4-440e-9826-fe1af414521b)

## Related Officers

- [Wenzheng Zhang](https://www.globalkeysolutions.net/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)

Company: https://www.globalkeysolutions.net/companies/gram-laboratories-inc/f54a2075-d931-4c44-a97c-e63f05375d9a

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