Regulatory Focus™ > News Articles > 2019 > 6 > FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers

FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers

Posted 25 June 2019 | By Michael Mezher 

FDA Warns Chinese, Indian Drugmakers and US-Based Kratom Sellers

The US Food and Drug Administration (FDA) earlier this month warned Chinese drugmaker Xi’an Livingbond Nonwoven Products Corp. and Indian homeopathic drugmaker Rxhomeo Private Limited over good manufacturing practice (GMP) violations stemming from inspections conducted earlier this year.
 
Based on the observations identified during the inspections, FDA placed the firms on Import Alert in April and May, respectively.
 
FDA also announced Tuesday that it has warned two US-based companies, Kratom NC and Cali Botanicals, for marketing kratom products through their websites and social media.
 
Xi’an Livingbond
 
In its warning letter to Xi’an Livingbond, FDA cites the company for failing to conduct identity and strength testing for some of its products and for lacking both an adequate quality control unit and an effective program for monitoring manufacturing operations.
 
According to FDA, Xi’an Livingbond failed to test over-the-counter (OTC) drug products to ensure they meet their identity and strength specifications before being released for distribution to the US. FDA also says the company failed to conduct identity, purity and strength testing for incoming active pharmaceutical ingredients (API) from third party suppliers.
 
The warning letter accuses the company of failing to set up an “ongoing program for monitoring process control to ensure stable manufacturing operations.”
 
“Your quality unit failed to establish written procedures for multiple responsibilities, such as cGMP training, annual product review (APR), and stability program,” FDA writes.
 
Rxhomeo Private Limited
 
Similarly, FDA warned Indian homeopathic drugmaker Rxhomeo for failing to test the bulk ingredients it used in its products for purity, strength and quality.
 
FDA also cited the company for failing to keep adequate batch control records. According to the agency, the company’s batch control records lacked numerous details and multiple products were found to share a single master batch record.
 
Additionally, FDA says the company’s quality unit “failed to provide adequate oversight over [its] manufacturing processes” and the company’s quality assurance procedures did “not define and describe the structure, function and responsibilities for the [quality unit].”
 
Kratom Warning Letters
 
The two warning letters to online kratom sellers continue an enforcement effort by FDA targeting companies that distribute and market kratom-based products.
 
In both warning letters, FDA accuses the companies of marketing unapproved new drugs and misbranded drugs based on claims that their kratom-based products can treat opioid addiction.
 
In a statement released alongside the two warning letters, Acting FDA Commissioner Ned Sharpless said: “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”
 
Warning Letters: Xi’an Livingbond, Rxhomeo Private Limited, Kratom NC, Cali Botanicals
 
Kratom Statement

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