FDA Sends Warning Letter To Maker of Mr. Lulu Sunscreen Drops

The US Food and Drug Administration (FDA) has sent a warning letter for violations of CGMP regulations to Mr. Lulu LLC, a California-based company.

The June 1, 2023 letter, which addressed to Roi Chairat, came after the agency conducted an inspection of the company’s manufacturing facility in Claremont, CA between November 30 and December 9, 2022.

The warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 

During its inspection, FDA investigators observed specific violations including failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.

FDA said the company failed to perform adequate release testing for each batch of your drug product prior to distribution. The agency said the company released multiple batches of over-the-counter (OTC) Mr. Lulu Sunscreen Drops SPF32 to the US market without adequate testing of zinc oxide and titanium dioxide content.

According to FDA, the company said that it does not perform assay testing on OTC finished drug products prior to release, but it evaluates drug products for scent, appearance, and texture before release a batch for distribution.

“Additionally, these testing results are not documented and there are no written procedures for the review and release of finished drug products,” wrote FDA in the letter.

FDA said the company failed to adequately test incoming components for identity before using them to manufacture your drug products.

Further FDA also stated that Mr. Lulu used food-grade titanium dioxide to manufacture Mr. Lulu Sunscreen Drops SPF32 and did not ensure that the titanium dioxide conformed to United States Pharmacopeia (USP) specifications as required.

FDA also took issue with the company’s process validation, equipment qualification and cleaning validation and batch production records and quality systems.