Three European and one Chinese drugmakers slammed by US FDA

By Dan Stanton contact

- Last updated on GMT

Image: iStock/CountDuckula
Image: iStock/CountDuckula

Related tags: Pharmaceutical drug, Fda

The US FDA has issued fours warnings against foreign drugmakers, citing reasons including problems with QC, a non-registered facility, and finished products that “did not contain any of the labeled active ingredient.”

The Agency published a string of warning letters yesterday, following inspections which observed cGMP violations at facilities run by firms in China, the UK, The Netherlands, Switzerland and China.

Yangzhou Hengyuan Daily Chemical Plastic

The US Food and Drug Administration (FDA) inspected the Chinese company’s facility in Yangzhou, Jiangsu in January this year and observed failures to provide adequate written production and control procedures.

“FDA collected samples of your (b)(4) batch #(b)(4) at the port of entry,”​ the warning letter​ states. “FDA Laboratory analysis found that your (b)(4) did not contain any of the labeled active ingredient, (b)(4). FDA denied entry of the shipment accordingly and notified your customer, (b)(4), which filed a complaint with you.”

The FDA also pulled the firm up on its lack of appropriate laboratory determination of satisfactory conformance.

For example: “Your investigation indicated the warehouse released the wrong active ingredient for batch #(b)(4). This was the first of multiple errors that led to adding the wrong ingredient to your drug product.”

According to its website​, the company makes consumer health products including toothpastes and ‘hotel amenities,’ but the FDA letter indicate the facility also makes finished pharmaceuticals.

Delarange Cosmetics & Healthcare

An inspection at the firm’s Zeewolde, The Netherlands at the end of May found significant violations of current good manufacturing practice (CGMP), the Agency said in the letter​.

These included problems in determining strength of active ingredients in private label products and a failure to establish an appropriate quality control unit. The FDA also found the company had failed to establish written procedures for cleaning and maintenance of equipment.

“You manufacture (b)(4) for the U.S. market on the same equipment that you use for manufacturing other products – including (b)(4). Your failure to adequately clean equipment between products risks contaminating your drugs with other potentially toxic chemicals.”

Laboratoire Sintyl

Over to Switzerland, and a facility run by Laboratoire Sintyl in Geneva inspected in June was also pulled up on quality control problems and failure to test the identity and strength of active ingredients.

The letter​ also noted the firm “failed to ensure the identity of components sourced from various suppliers,”​ and criticised the cleanliness of equipment.

“You failed to clean and maintain your (b)(4) at appropriate intervals to prevent malfunctions or contamination of your drug products. (21 CFR 211.67(d)). During the inspection, we observed reddish brown discoloration consistent with rust on your (b)(4).”

Wallace Cameron International

And while the FDA did not carry out an inspection Wallace Cameron International – a firm which makes and supplies mostly first aid dispensers and devices – it did issue a letter​ following a review of drugs which entered the US from its facility in Wishaw, UK.

“Our records indicate that you have not registered your establishment for 2016, but have continued to manufacture, prepare, propagate, compound, or process drugs that were not listed but being imported or offered for import into the United States during this time.”

The Agency did not reveal which drug had entered the US.

Related topics: Markets & Regulations

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