FDA Warns Four Foreign Drug Manufacturers

Regulatory NewsRegulatory News | 11 October 2016 |  By 

The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland.

The warning letters are part of a wider crackdown by FDA on foreign drug manufacturers, particularly in China and India. Data manipulation has been a primary concern for FDA, in addition to trying to deal with manufacturers that refuse inspections.


For the warning letter sent 26 September to Yangzhou Hengyuan Daily Chemical Plastic Co., FDA said that its laboratory analysis of batches made at the site found that the product “did not contain any of the labeled active ingredient” and then FDA denied shipments of product made at the site to the US.

Inspectors also said that the company “acknowledged that your firm did not test all batches of finished drug product prior to release. For example, in 2015 you tested only five of the [redacted] batches shipped to the United States. We note you did not perform the active ingredient assay for batch [redacted] prior to release. FDA analysis showed this batch contained no active ingredient.”

The company’s investigation indicated its warehouse released the wrong active ingredient for at least one batch and FDA said this was “the first of multiple errors that led to adding the wrong ingredient to your drug product.”

Yanzhou was placed on Import Alert 66-40 on 12 August. More than 50 other Chinese drug and active pharmaceutical ingredient (API) manufacturing sites are also on import alert, meaning their products are refused entry into the US.

“Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the warning letter adds.


Following FDA’s inspection of the Geneva-based manufacturing site of Laboratoire Sintyl S.A. from 20 June to 23 June, FDA uncovered six specific violations, including a failure to test finished batches of drugs, a failure to clean manufacturing equipment and no data to demonstrate that the chemical and physical properties of products remain acceptable throughout their shelf lives.

The Swiss company said it ceased manufacturing over-the-counter drugs, but FDA said the firm has not kept FDA informed of the progress and has “yet to provide FDA with any evidence to document that a [redacted] has occurred,” according to the warning letter.


FDA on 29 September sent a warning letter to Scotland-based Wallace Cameron International, which failed to fulfill its establishment registration and drug listing obligations under the Federal Food, Drug, and Cosmetic Act.

“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 warning letter says.


Zeewolde-based Delarange Cosmetics & Healthcare BV, meanwhile, received a warning letter on 29 September after FDA inspectors found the firm “does not have a quality unit to review and approve the release of your drugs,” and that the company did not test finished products and did not establish final specifications for release testing of its drugs.

The company told FDA in June that it will no longer produce product for the US market and that it chose “not to enter into substantive discussion about the observations described” by FDA in the warning letter, though FDA added that it “did not commit to any corrective actions regarding the CGMP violations observed on the inspection.”


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