Company: Faci S.P.A.
Subject: Failure to Register and List
Issuer: Center for Drug Evaluation and Research
Issued: May 24, 2012 Closed: June 14, 2012
Source ucm310877 Archive Code:

Faci S.P.A. 5/24/12

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Silver Spring, MD 20993

Warning Letter

WL: 300-12-010

May 24th, 2012

Mr. Franco Rossi
Faci S.P.A
Via Privata Devoto, 36
Carasco, GE 16042, Italy
FEI: 3003673289

Dear Mr. Rossi:

The United States Food and Drug Administration (FDA) has reviewed entries regarding shipments of drugs into the United States from the establishment listed above, as well as information on file concerning your establishment’s drug registration and listing. This review revealed that you have not fulfilled your registration obligations under the Federal Food, Drug, and Cosmetic Act (the Act). Our records indicate that you have not registered your establishment within 2011 or 2012, but have continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the United States during this time. By letter dated October 11, 2011, FDA notified you that records indicated your establishment was not duly registered and informed of the steps you needed to take to become duly registered and to list your products. Our records indicate you have not availed yourself of this opportunity to register.

Under section 510(i)(1) of the Act (21 U.S.C. § 360(i)(1)), you are required to submit registration information annually by electronic means for each foreign establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States. The failure to register in accordance with this provision is a prohibited act under section 301(p) of the Act (21 U.S.C. § 331(p)).

In addition, no drug may be imported or offered for import into the United States unless it is listed as required in Title 21 of the Code of Federal Regulations (CFR), part 207, subpart C, and manufactured, prepared, propagated, compounded, or processed at a registered foreign drug establishment. 21 CFR § 207.40(b). A drug offered for import into the United States may be refused admission under section 801(o) of the Act (21 U.S.C. § 381(o)) if the importer, owner, or consignee is not able to provide a statement of the registration under section 510(i) (21 U.S.C. § 360(i)) of the establishment that manufactured it. Likewise, a drug offered for import may be refused admission under section 801(a)(3) of the Act (21 U.S.C. § 381(a)(3)), if the drug appears to be adulterated or misbranded. Under section 502(o) of the Act (21 U.S.C. § 352(o)), the failure to list a drug as required under section 510(j) or to supply certain notice or information about the drug required under section 510 renders a drug misbranded. FDA regulations in 21 CFR part 207 specify the requirements for listing drugs and updating drug listing information in accordance with section 510(j) of the statute, and include requirements to update listings to reflect any material changes in information already submitted, as well as to report the discontinuance of any drugs. 21 CFR § 207.30(a). Drug listings must include the registration number of the establishment(s) at which the listed drugs are produced. 21 CFR § 207.25(b)(7). Because your establishment registration has lapsed, any drug listings indicating that establishment as the responsible manufacturing location would appear to be out of date, and thus create an appearance of misbranding under section 502(o) of the Act (21 U.S.C. § 502(o)).

To remedy the above-mentioned violation of the Act and ensure that your drugs are not subject to refusal of admission to the United States on the bases identified above, you should take action immediately to register the establishment at via Privata Devoto, 36, Carasco, GE 16042, Italy, and ensure that you have properly listed drugs being offered for import to the United States that are manufactured there.

Within fifteen working days of receipt of this letter, please notify this office in writing of the actions taken to correct this violation of the Act. If you intend to continue to produce drugs that are being imported or offered for import into the United States, you must complete the required registration and listing. In such case, please inform us that you have fulfilled these requirements in response to this letter. If you cannot complete the required corrective action within fifteen business days, state the reason for the delay and the date by which you will have completed the correction. If you instead intend to cease producing drugs that are being imported or offered for import into the United States, please notify us of this intent and provide notice of discontinuance of production of those drugs in accordance with section 510(j)(2) of the Act (21 U.S.C. § 360(j)(2)) and 21 CFR part 207. Please direct correspondence to:

Donovan F. Duggan
Center for Drug Evaluation and Research/Office of Compliance
White Oak, Building 51, Rm 4288
10903 New Hampshire Ave
Tel: (301) 796-3100
Fax: (301) 847-8747

Notice of this letter may be provided to the importers and consignees of record for shipments of drugs offered for import into the United States in 2011 or 2012 that were manufactured in the establishment that was not duly registered.

FDA no longer accepts paper submissions for Registration and Listing. Establishment registration information or renewal should be submitted via Structured Product Labeling (SPL) using the new electronic system. For information on how to use the electronic system visit:

Douglas Stearn
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research