# China NMPA Drug Inspection - Hubei Yitai Pharmaceutical Co., Ltd - Lansoprazole enteric-coated tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hubei-yitai-pharmaceutical-co-ltd/cd4d082f-a492-44f7-a0fd-4506928f5f9e/
Source feed: China

> China NMPA drug inspection for Hubei Yitai Pharmaceutical Co., Ltd published June 30, 2017. Drug: Lansoprazole enteric-coated tablets. The Shaanxi Provincial Food and Drug Administration (Shaanxi FDA) released an announcement on June 30, 2017, detailing f

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shaanxi Province Drug Quality Bulletin
- Company Name: Hubei Yitai Pharmaceutical Co., Ltd
- Publication Date: 2017-06-30
- Drug Name: Lansoprazole enteric-coated tablets
- Inspection Finding: Inspection did not meet regulations
- Action Taken: The relevant municipal (county, district) food and drug administration departments have taken necessary control measures and are investigating and handling the matter in accordance with relevant laws and regulations. The sampled unit did not store the drugs according to the instructions.
- Summary: The Shaanxi Provincial Food and Drug Administration (Shaanxi FDA) released an announcement on June 30, 2017, detailing findings from its 6th drug sampling inspection of the year. This province-wide initiative aimed to bolster drug supervision and protect public health. The inspection identified 22 batches of non-compliant drugs from various manufacturers, encompassing both Traditional Chinese Medicine (TCM) producers like Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd., and general pharmaceutical companies such as Hubei Keyi Pharmaceutical Co., Ltd. The primary violations included failures in "Content Determination," "Properties," "Identification," "Appearance," and general "Inspection" parameters. Many TCM products did not meet specified standards for active ingredient levels or characteristic qualities. Issues also involved packaging, with low borosilicate glass ampoules failing a breaking force test, and improper storage conditions for Lansoprazole Enteric-coated Tablets at a sampled facility. Inspections were conducted under the regulatory framework of the *Chinese Pharmacopoeia*, specific provincial standards for TCM pieces, and national standards for pharmaceutical packaging materials. In response, local food and drug regulatory departments have implemented necessary control measures for the implicated entities and are initiating investigations and enforcement actions in accordance with relevant laws and regulations.

Company: https://www.globalkeysolutions.net/companies/hubei-yitai-pharmaceutical-co-ltd/5af81d39-2c88-47d8-b8fc-6627329507f3/