# FDA 483 - Valentine Enterprises, Inc. - October 24, 2024

Source: https://www.keypedia.com/records/483/valentine-enterprises-inc/ec3f4da5-24da-437c-b703-f3e1bf3f82a1

> FDA 483 for Valentine Enterprises, Inc. on October 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valentine Enterprises, Inc.
- Inspection Date: 2024-10-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Valentine Enterprises, Inc., a dietary supplement manufacturer in Lawrenceville, GA, was cited for significant deficiencies in quality control and record-keeping during an FDA inspection. Observations included failure to establish complete product and component specifications, releasing adulterated products due to inadequate microbial testing, and releasing out-of-specification products. The firm also lacked comprehensive Master Manufacturing Records and Batch Production Records.

## Related Documents

- [WARNING_LETTER - 2024-10-24](https://www.keypedia.com/records/warning_letter/valentine-enterprises-inc/12aab86f-8b49-410c-9409-2ffefef511bf)

## Related Officers

- [Gary C. Pecic](https://www.keypedia.com/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)
- [Sandra R. Saunders](https://www.keypedia.com/people/sandra-r-saunders/3bc09d03-02f6-4287-bc01-6cc451eaecb7)
- [Sandra K. Saunders](https://www.keypedia.com/people/sandra-k-saunders/888ab23c-5053-4bbc-8ddc-d86abc25dc78)
- [Stephanie L. Kelly](https://www.keypedia.com/people/stephanie-l-kelly/d0b0409f-85a2-457c-b955-38fc399cf21f)
- [Gary C Decicco](https://www.keypedia.com/people/gary-c-decicco/e0b848f4-a42f-49b7-bbae-9983029e4069)

Company: https://www.keypedia.com/companies/valentine-enterprises-inc/4a176a6d-efc8-4886-9b36-b274f5071695

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7