U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Multimedical S.R.L. - 444772 - 06/08/2015
  1. Warning Letters

CLOSEOUT LETTER

Multimedical S.R.L. MARCS-CMS 444772 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices

Recipient:
Recipient Name
Oreste Gavetti
Recipient Title
President
Multimedical S.R.L.

Via G Rossa, 71
Zona Ind. Gerbolina
46019 Mantua
Italy

Issuing Office:
Division of International Compliance Operations

United States


Dear Mr. Gavetti:

The United States Food and Drug Administration (FDA) completed an evaluation of your firm's response dated March 2, 2015, April 14, 2015, and May 19, 2015, in response to our Warning Letter (#444772, dated February 13, 2015). Based on our evaluation, it appears that your firm's response has adequately addressed the violations contained in the Warning Letter.

Please be advised that it is your firm's responsibility to assure compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.

A Warning Letter close-out letter will not be issued until an FDA follow-up inspection has been conducted to verify that corrections and/or corrective actions (which must address systemic problems) have been implemented by your firm. An FDA staff member will contact you to arrange a mutually convenient date for conducting a follow-up inspection.

If you have any questions about the contents of this letter, please contact Daniel Walter at 301-796-5587 or 301-847-8139 (fax).

Sincerely yours,
/S/
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health