# Martin Marietta Inc – FDA 483, Aug 21, 2026

Source: https://www.keypedia.com/records/483/martin-marietta-inc/b94701ac-a60c-4d74-891b-abfdf49906a7

> FDA 483 for Martin Marietta Inc on August 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Martin Marietta Inc
- Inspection Date: 2026-08-21
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Martin Marietta, an API manufacturer in Greendale, IN, received a Form 483 with six observations highlighting significant deficiencies in their manufacturing processes. Issues included inadequate cleaning validation procedures, poor facility sanitation with unsecured insulation, and incomplete batch production records. The firm also failed to ensure the suitability of raw materials through proper testing and did not adequately evaluate critical material suppliers or verify their Certificates of Analysis.

## Related Documents

- [483 - 2022-07-27](https://www.keypedia.com/records/483/martin-marietta-inc/c0214e2b-be17-4bff-b659-186a25a012fd) — date: July 27, 2022

## Related Officers

- [Shannon L. Maisano](https://www.keypedia.com/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.keypedia.com/companies/martin-marietta-inc/7541d032-00cd-4285-91e7-b149d23a1db2

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03