Sanitor Corporation
FDA issued a warning letter to Sanitor Corporation (Stanton, CA) following a May–June 2021 inspection that found multiple CGMP violations including inadequate quality control, microbial contamination in hand sanitizer batches, data integrity failures, and distribution of drug products before testing was complete. The company also marketed unapproved new drug products — hydroquinone-based skin bleaching/lightening products — without FDA approval, and one acne product was found to be misbranded for failing to bear a required statement of identity. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.
Flagged claims (5)
Indications: Skin lightener
Indicated for the depigmentation of dark areas of the skin such as age spots, liver spots, freckles, and other unwanted areas of melanin hyperpigmentation.
[I]ndicated for the gradual lightening of hyperpigmented skin conditions, such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Helps to unclog pores with deep cleaning action to prevent future breakouts . . . Drug Facts …. Purpose: Acne Treatment.
indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
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