# China NMPA Drug Inspection - Xi"an Ark Haili Technology Co., Ltd. - Polyester/low-density polyethylene pharmaceutical composite film

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/xian-ark-haili-technology-co-ltd/e146647e-3bc4-4c84-a16a-68a5637d49bf/
Source feed: China

> China NMPA drug inspection for Xi"an Ark Haili Technology Co., Ltd. published July 30, 2020. Drug: Polyester/low-density polyethylene pharmaceutical composite film. The Shaanxi Provincial Drug Administration released an announcement on July 30, 2020, detailing the results of its seven

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shaanxi Province Drug Quality Bulletin
- Company Name: Xi"an Ark Haili Technology Co., Ltd.
- Publication Date: 2020-07-30
- Drug Name: Polyester/low-density polyethylene pharmaceutical composite film
- Inspection Finding: The product does not meet the requirements; the non-compliant item is [barrier performance].
- Action Taken: The relevant municipal (county, district) drug regulatory authorities have taken necessary control measures and are investigating and handling the matter in accordance with relevant laws and regulations.
- Summary: The Shaanxi Provincial Drug Administration released an announcement on July 30, 2020, detailing the results of its seventh drug sampling inspection for the year. The inspection identified five batches of products that failed to meet quality standards, involving four specific companies: Anhui Jin Fu Rong Traditional Chinese Medicine Pieces Co., Ltd., Anhui Hongxin Pharmaceutical Development Co., Ltd., Xi'an Fangzhou Haili Technology Co., Ltd., and Baoji Xiangyuan Traditional Chinese Medicine Pieces Co., Ltd. The main issues cited included physical appearance flaws, failed chemical inspections, and inadequate extractive levels in herbal medicines, as well as poor barrier performance in pharmaceutical packaging materials. These products were evaluated under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition) and the National Pharmaceutical Packaging Material Standards. In response to these findings, the provincial administration has directed local drug regulatory departments to implement control measures on the non-compliant batches. Furthermore, the authorities have launched formal investigations to handle the involved units according to relevant laws and regulations, ensuring that all products meet the necessary safety requirements for public use.

Company: https://www.globalkeysolutions.net/companies/xian-ark-haili-technology-co-ltd/cb46d0e9-78b8-489f-a602-5f3ed55f428e/