# FDA 483 - Southern Spectrographic Laboratory, Inc. - May 11, 2024

Source: https://www.keypedia.com/records/483/southern-spectrographic-laboratory-inc/c25a0490-9b33-4d7f-8881-6f5c2a22195d

> FDA 483 for Southern Spectrographic Laboratory, Inc. on May 11, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Southern Spectrographic Laboratory, Inc.
- Inspection Date: 2024-05-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Southern Spectrographic Laboratory, Inc. in Arlington, TX, a contract testing laboratory, revealed significant deficiencies in their quality systems. Observations included inadequate laboratory controls with missing test procedures and rounding guidelines, lack of justification for expiration dates of critical standards, and a failure of the quality control unit to review and approve written procedures. Furthermore, the inspection found that all laboratory employees had not received required cGMP/cGXP training, indicating systemic issues in ensuring the quality and purity of drug products tested.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Mahanty Lizardi, CSO](https://www.keypedia.com/people/mahanty-lizardi-cso/5fad3d4d-d52e-4d75-b0ca-cc3ec857b1c2)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/southern-spectrographic-laboratory-inc/3c5fe8da-6d1c-4206-b620-e4e4f2d3f5f2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab