# FDA 483 - Gram Laboratories Inc - September 04, 2015

Source: https://www.globalkeysolutions.net/records/483/gram-laboratories-inc/5581dd6f-53f4-440e-9826-fe1af414521b

> FDA 483 for Gram Laboratories Inc on September 04, 2015. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gram Laboratories Inc
- Inspection Date: 2015-09-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Gram Laboratories, Inc., a contracted control testing laboratory in Irvine, CA, was cited for significant deficiencies in its quality control unit, laboratory computer system controls, and investigation procedures. The inspection revealed issues with data integrity, unvalidated spreadsheets, inadequate calibration procedures, and insufficient employee training, indicating a lack of robust quality management.

## Related Documents

- [483 - 2025-04-08](https://www.globalkeysolutions.net/records/483/gram-laboratories-inc/79f9c587-ce7a-4b46-8471-e6bfdd9106c4)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)
- [investigator](https://www.globalkeysolutions.net/people/virgilio-f-pacio/9d957c91-b8e9-4e71-ba2e-19b3eccd0e38)
- [Theresa Kirkham](https://www.globalkeysolutions.net/people/theresa-kirkham/c7d8aad0-d162-4fac-a1ba-4649c36fd714)

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

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