# FDA 483 - Eagle Labs Inc. - December 06, 2023

Source: https://www.keypedia.com/records/483/eagle-labs-inc/415d0084-2686-40df-bf42-3b8078844d55

> FDA 483 for Eagle Labs Inc. on December 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eagle Labs Inc.
- Inspection Date: 2023-12-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: During an FDA inspection from November 29 to December 6, 2023, Eagle Labs Inc., a contract manufacturer in Seminole, FL, was cited for two observations. The firm failed to follow written procedures for equipment cleaning and maintenance, including issues with major cleans and cleaning validation for non-dedicated drums. Additionally, the inspection found that written production and process control procedures were not followed and documented correctly during process validation activities.

## Related Documents

- [483 - 2024-10-31](https://www.keypedia.com/records/483/eagle-labs-inc/20e3a64d-6c2a-4b3e-8912-5dff74121dc1)

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.keypedia.com/companies/eagle-labs-inc/e0addf0e-7d1b-4221-940b-18435b523a6f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6