Swiss skin-care company Laboratoire Sintyl slapped with FDA warning letter

The FDA has slapped Swiss skin-care manufacturer Laboratoire Sintyl with a warning letter after an inspection of its Geneva plant uncovered records keeping and batch testing issues, and found what appeared to be rust in some equipment.

Several batches of the product manufactured at the facility were distributed in the U.S. despite the company being informed of the issues, the agency said.

In the letter posted on the FDA’s website this week, the agency said that during a June inspection of the plant company officials admitted that they didn’t have an independent quality control unit. 

Infographic

[Infographic] Machine Learning, Statistics and Optimizing Outcomes

In our infographic, we outline the potential of fusing machine learning and statistics algorithms together to more efficiently analyze clinical trial data output and ultimately revolutionize clinical research.

Additionally, the company was cited for failing to test batches of its drug products to measure the identity and strength of its active ingredients, not cleaning and maintaining its equipment properly, and failing to collect date that would show the chemical and physical properties of its products would remain acceptable throughout their shelf lives.

Laboratoire Sintyl, which is best known for its skin care product Physiodermie, wasn’t hit with an import ban, but the agency strongly recommended it hire a consultant to help it conform to CGMP standards.

- here’s the FDA warning letter

Related Article:
Counterfeit Harvoni turns up in Switzerland, Israel

Suggested Articles

Novartis' AveXis will use Catalent for some manufacturing of its newly approved gene therapy Zolgensma and more manufacturing news of note.

Pharmacy chain Rite Aid has partnered with Google to have their drug recycling stations easily searchable on Google Maps. 

Precision BioSciences says it will have a manufacturing facility for its off-the-shelf CAR-T therapies up and running in the fourth quarter.