In March, multiple Monat employees confirmed that the FDA surprised the company with an inspection of their Florida manufacturing plant. Monat executives quickly issued a statement afterwards saying that the FDA “found no violations or other matters of significant concern”, which we now know is a lie based on the official inspection report released this week.
The FDA inspector found Monat cosmetics being “prepared, packed, and held under insanitary conditions whereby it may have become contaminated with filth.” The report also notes that multiple products were at risk of cross-contamination, and processing equipment was still covered in residue after multiple “cleanings” by facility staff.
It’s understandable why Monat worked hard to suppress the FDA’s report—it’s already fighting multiple class-action lawsuits that claim the company’s products cause significant hair loss and scalp lesions. These findings aren’t good for the company that claims to sell “premium” haircare products.
You can read the full details of the report below:
- On 03/12/2018 I observed reactor located in the manufacturing room with an open lid while for Men Shampoo + Conditioner Lot# 18J0308038 was held inside as an in-process product.
- On 03/12/2018 I observed residues of products in the upper part of reactor and in the lid after a cleaning was performed to it on 03/08/2018 and a re-cleaning performed on 03/12/2018. Reactor was ready to process a new batch of hair care product. The lid of reactor was open. Reactors and are located next to
- On 03/12/2018 I observed white hoses used to pump product to the hopper of the filling lines resting on a table near filling line The hoses were already cleaned and sanitized and both ends were without the protective caps that serve as a method to prevent contamination, leaving the interior surfaces exposed to the environment.
- On 03/12/2018 a personal item (employee jacket) was stored in close proximity to filling line while Black Shampoo + Conditioner Lot# 18J0308039 was being processed in this line. The jacket was specifically located next to the air hose used by this filling line and a white hose used to fill the hopper with a product.
- On 03/19/2018 I observed that empty containers of Rejuvabeads (2.4oz) Lot# 18J0305030 were left uncovered and exposed in filling line after the employees finished their working day. The containers have an open end where the product is filled in.
The report concludes by saying that this document is only a list of observations and “do not represent a final Agency determination regarding your compliance.” It remains to be seen what action, if any, the FDA takes in the future against Monat.
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