Resultaten zoeken voor “cpnp notification”

MoCRA requires cosmetic facility registrations to be renewed with the FDA every two years. We check your existing registration in Cosmetics Direct,...

Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...

Under MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 y...

Under MoCRA, the responsible person must list each cosmetic product with FDA and update listings every year. We prepare and submit listings in Cosm...

OTC drugs such as sunscreens, acne treatments and antiperspirants must carry a Drug Facts label in the format set by 21 CFR 201.66, with wording th...

Foreign cosmetic facilities must register with the FDA under MoCRA and name a US agent. This package covers both: we prepare and submit your regist...

Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Saf...

MoCRA Enterprise is a 12-month programme for brands with 100 or more SKUs or several facilities. It adds a dedicated regulatory manager, a 1-busine...

Medical device labels sold in the US must meet 21 CFR Part 801, and most need a unique device identifier under 21 CFR Part 830. We review your labe...

Each OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug li...

Under MoCRA, every facility that manufactures or processes cosmetics for US distribution must register with the FDA and renew every two years. We p...

MoCRA requires every cosmetic facility outside the US to name a US agent in its FDA registration. Phoenix Safety Consultants LLC acts as your US ag...

US cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event ...

Foreign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Cons...

MoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for ...