The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.
Adulteration, misbranding and design validation cause a problem for one company.
Inquiries from FDA cannot be ignored. You must respond, especially if the agency contacts your establishment more than once.