# China NMPA Inspection - Qingdao Hantang Biotechnology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qingdao-hantang-biotechnology-co-ltd/1e126d6f-ffce-4b73-bc3f-66f8b6139052/
Source feed: China

> China NMPA unannounced inspection for Qingdao Hantang Biotechnology Co., Ltd. published August 15, 2018. An unannounced compliance inspection of Qingdao Hantang Biotechnology Co., Ltd. was conducted on July 26-27, 2018, based on the Good Manufacturing Pra

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Qingdao Hantang Biotechnology Co., Ltd.
- Company Name: Qingdao Hantang Biotechnology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced compliance inspection of Qingdao Hantang Biotechnology Co., Ltd. was conducted on July 26-27, 2018, based on the Good Manufacturing Practice for Medical Devices and its Appendix for In Vitro Diagnostic Reagents. The inspection identified 11 general deficiencies in the company's operations, focusing on the Helicobacter pylori Antibody Detection Kit (Colloidal Gold Method).

Key issues included improper storage of critical raw materials like antigens and antibodies, and significant failures in document control, such as missing "Quality Manual" change records and non-compliance with established procedures for other document changes. Production records were found to be incomplete, with unexplained discrepancies in diluent volumes. The company lacked essential raw material lists, quality, and acceptance standards for key components, and incoming material inspection reports were deficient, missing required purity tests and manufacturer documentation.

Furthermore, environmental controls were inadequate, evidenced by temperature and humidity deviations in critical production and storage areas, and issues with air conditioning system markings and record-keeping for fresh air valves. Personnel responsible for maintaining critical air and water purification systems lacked appropriate training. Water treatment sampling points and pipe flow directions were unmarked, and finished product storage temperature records showed inconsistencies. Finally, the company could not provide verification for the shelf life of a key raw material.

The Shandong Provincial Food and Drug Administration was tasked to mandate the company's rectification of all identified issues, assess product safety risks, and recall any hazardous products. Follow-up inspections are required, with the rectification status to be reported to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/qingdao-hantang-biotechnology-co-ltd/88af9d7c-b569-45e1-9e49-df124177d4e5/