Hacienda Morales dba Granja Avicola Morales

CLOSEOUT LETTER Hacienda Morales dba Granja Avicola Morales June 07, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Hacienda Morales dba Granja Avicola Morales United States Issuing Office: United States Office of Regulatory Affairs Office of Human and Animal Food Operations East Division IV Compliance Branch 466 Avenida Fernández Juncos San Juan, Puerto Rico 00901-3223 Tel: (787) 729-8500 June 07, 2018 18-HAFE4-WLCOL-06 / CMS No. 397823 VIA UNITED PARCEL SERVICE NEXT DAY - SIGNATURE REQUIRED Mr. Samuel Morales Arce, Owner Hacienda Morales dba Granja Avicola Morales Road 404, Km. 8.6 Moca, Puerto Rico 00676 Re: Warning Letter, 13-SJN-WL-06 dated 09/23/2013 Dear Mr. Morales: During a follow-up visit to your facility during 07/31/2017 - 08/01/2017 by a Food and Drug Administration investigator, it was determined that your firm is out-of-business. It appears that the violations contained in the Warning Letter, 13-SJN-WL-06, dated 09/23/2013, will not require additional FDA inspection activities. However, should you decide to resume business operations that fall under the registration requirements in Sec. 415 of the Federal Food, Drug and Cosmetics Act (the Act), [21 USC § 350d] and its implementing regulation 21 CFR Part 1, Subpart H, you must register the facility with FDA. Registration may be accomplished on-line at http://www.access.fda.gov . We strongly encourage the use of electronic registration, because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, the owner, operator, or agent in charge of the facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA Food Facility Registration form, Form FDA 3537 (enclosed). Additionally, this form may be obtained by calling the FDA Industry Systems Help Desk at 1 (800) 216-7331 or (301) 575-0156 or by writing to the agency at the following address: U.S. Food and Drug Administration, HFS-681 5100 Paint Branch Parkway College Park, MD 20993 When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter will not preclude any future regulatory action should violations be observed during subsequent inspections or through other means. Kind regards, /S/ Edwin Ramos Director of Compliance Branch OHAFO East Division IV Content current as of: 06/11/2018