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Regulatory Focus™ > News Articles > 2019 > 9 > FDA Warns Chinese, Costa Rican Drugmakers

FDA Warns Chinese, Costa Rican Drugmakers

Posted 04 September 2019 | By Michael Mezher 

FDA Warns Chinese, Costa Rican Drugmakers

The US Food and Drug Administration (FDA) last month warned Chinese active pharmaceutical ingredient (API) distributor Yino, Inc. and Costa Rican over-the-counter (OTC) drugmaker Polimeros y Servicios S.A. over good manufacturing practice (GMP) violations at their respective facilities.
 
Yino
 
In FDA’s warning letter to Yino, the agency takes the company to task after a five-day inspection of the company’s Chongqing facility in March identified issues with its handling of re-labeled API distributed to the US.
 
The issues observed during the inspection led FDA to place Yino on import alert in August.
 
According to FDA, Yino re-labeled API made by other companies and distributed it to the US without including information about the original manufacturer for several lots of an API used in injectable drugs made by compounding facilities.
 
FDA also cited the company for failing to implement effective quality oversight of its documentation practices. In addition to lacking information about the original manufacturer of its API in certificates of analysis, FDA says the certificates also lacked signatures and dates from the company’s quality unit.
 
Polimeros y Servicios S.A.
 
FDA’s warning letter to Polimeros y Servicios comes after a five-day inspection of the firm’s San Jose, Costa Rica facility last February that landed the company on import alert in July.
 
The warning letter cites four issues related to the company’s product testing and equipment cleaning and maintenance procedures for its OTC products, which FDA says include repeat violations from a 2017 inspection.
 
“Our inspection found that you did not test your [OTC] finished drug products to determine whether each batch meets identity and strength of active ingredient specifications before releasing those drug products to the US market,” FDA writes.
 
FDA says the company also failed to verify the identity of API sourced from other manufacturers to determine their identity, purity and strength, purity and other quality attributes before releasing them and did not conduct adequate stability testing for its products.
 
Additionally, FDA says Polimeros y Servicios did not properly validate its cleaning and maintenance procedures for non-dedicated equipment used to manufacture multiple topical OTC drugs.
 
On top of the GMP issues cited in the letter, FDA says Polimeros y Servicios distributed unapproved new and misbranded drugs based on claims made on the labels and websites for three of its topical OTC products: Bioactil Pain Relieving Gel, Keractil Plus Antifungal Gel and Klearactil Acne Treatment.
 
Warning Letters: Yino, Inc., Polimeros y Servicios S.A.

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