Sterile artificial tears, ophthalmic lubricants, saline nasal sprays, and topical antiseptic manufacturers under intense FDA cGMP sterility and cleanroom water system scrutiny.
Download the normalized 5-year Excel dataset with FEI/DUNS mappings and FSVP checklists.
Buy Cleaned 5-Yr Excel ($39 • Gumroad Instant Checkout)An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.
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).
Contract manufacturer of preservative-free carboxymethylcellulose lubricating eye drops and isotonic nasal sprays. Placed on Import Alert 66-40 Red List following a 9-observation Form FDA 483 citing ISO 5 aseptic filling interventions and water-for-injection (WFI) biofilm excursions.
Modern Korean sterile hydrogel wound spray, hyaluronic contact lens rewetting drop, and OTC monograph topical analgesic factory. Detained when US private-label distributors omit Drug Facts active ingredient percentages or make non-monograph dry-eye therapeutic claims.
Across 5-year CBP/FDA OASIS records, Ophthalmic Drops, Nasal Sprays & OTC Monograph Drugs (FDA Industry Code 60–66 (Human OTC & Ophthalmic Drugs)) experiences a 27.1% detention rate among flagged overseas shippers with an average port hold of 35 calendar days across Newark, Miami, Los Angeles.
The primary statutory charge codes for Ophthalmic & OTC are INSANITARY_CONDITIONS, UNAPPROVED_NEW_DRUG, UNSAFE_COLOR. Key active Import Alerts include Import Alert 66-40 (Drugs Not Manufactured in Conformity with cGMP); Import Alert 66-79 (Foreign Establishments Refusing FDA Inspection); Import Alert 66-41 (Unapproved New Drugs Marketed as OTC). Historical refusal logs do not certify future admissibility.