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.
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
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