# FDA 483 - Seatex LLC - October 20, 2023

Source: https://www.keypedia.com/records/483/seatex-llc/35d3449f-0ba4-4965-82d0-39e6af331a96

> FDA 483 for Seatex LLC on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Seatex LLC
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Seatex LLC, an OTC drug manufacturer in Rosenberg, TX, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed inadequate laboratory controls, a lack of process validation, insufficient stability data for expiration dates, and incomplete laboratory records. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its drug products.

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.keypedia.com/companies/seatex-llc/4dd6c435-911b-40f7-85f1-e55b0582ba5c

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