# FDA 483 - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD - August 30, 2024

Source: https://www.globalkeysolutions.net/records/483/shantou-sez-baojie-industry-co-ltd/ad1097a2-362a-48b3-b55b-70557c7fd1bb

> FDA 483 for SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shantou S.E.Z Baojie Industry Co., Ltd, an OTC drug product manufacturer in Shantou, China, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included failure to test components, verify identity of ingredients, qualify equipment, maintain a proper stability program, retain reserve samples, validate test methods, provide batch records, and establish annual quality evaluations. These issues indicate a severe lack of adherence to good manufacturing practices, potentially impacting the safety, quality, and efficacy of drug products distributed to the US market.

## Related Officers

- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/shantou-sez-baojie-industry-co-ltd/3007408d-d8ab-41cb-8f95-1fc7ba49db04

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1