Contract OEM/ODM manufacturers of facial serums, colour cosmetics, sunscreens, and hydrogel masks scrutinized under MoCRA facility registration, unapproved drug claim enforcement, and batch color certification.
Download the normalized 5-year Excel dataset with FEI/DUNS mappings and FSVP checklists.
Buy Cleaned 5-Yr Excel ($39 • Gumroad Instant Checkout)The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.
The cosmetic or food item contains a dye/pigment either banned in the US or lacking an FDA batch certification number (e.g., FD&C Red No. 40 without batch cert).
An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.
High-volume private-label serum & eye-cream OEM in Baiyun District. Repeatedly detained at Los Angeles/Long Beach for therapeutic anti-aging/rosacea claims on outer cartons and uncertified CI 45410 (Red 28) pigment lots in lip oils.
ISO 22716 certified Korean hydrogel mask and PDRN ampoule manufacturer. Clean microbiological and facility inspection record, but US Amazon importers occasionally trigger Section 505(a) holds when retaining Korean 'functional cosmetic' SPF/whitening claims on US boxes.
Across 5-year CBP/FDA OASIS records, Cosmetics, Serums & MoCRA Skincare (FDA Industry Code 53 (Cosmetics)) experiences a 14.8% detention rate among flagged overseas shippers with an average port hold of 19 calendar days across Los Angeles, Newark.
The primary statutory charge codes for Cosmetics & Skincare are UNAPPROVED_NEW_DRUG, UNSAFE_COLOR, INSANITARY_CONDITIONS. Key active Import Alerts include Import Alert 66-41 (Unapproved New Drugs — OTC/Cosmetic Claims); Import Alert 53-06 (Cosmetics Adulterated with Unsafe Color Additives); Import Alert 53-17 (Microbiological Contamination in Cosmetics). Historical refusal logs do not certify future admissibility.