Written by situation.

Longer notes on the situations we are called into most often — what the requirement is, what the agency expects to see, and where files usually fail.

Each note covers one situation end to end: the legal basis, what FDA expects the file to show, and the points where a petition or an entry most often breaks down. They are written for the person who has to build the file.

FDA import alert removal

What an import alert does to your entries, and what a petition for removal has to prove.

Detention without physical examination

Answering a Notice of FDA Action: testimony, private laboratory analysis, reconditioning and refusal.

Food & beverage exporters

Registration, preventive controls, HACCP and labeling — and the four places food entries most often fail.

Medical devices & diagnostics

Classification, the right premarket route, and a quality system that survives an inspection.

Pharmaceuticals & APIs

CGMP that holds up under inspection, data integrity, and the import alert that covers a whole site.

Cosmetics & personal care

MoCRA registration and listing, colour additive rules, and the line between a cosmetic and a drug.