DEPARTMENT OF HEALTH & HUMAN SERVICES
February 15, 2012
VIA EXPRESS MAIL
Perla Escaba, Vice-President
Escaba Food Products, Inc.
Santa Ana, San Pablo City
Reference No.: 277018
Dear Ms. Escaba:
The U.S. Food and Drug Administration (FDA) inspected your acidified and low-acid canned food facility located in Barangay, Santa Ana, San Pablo City, Philippines 4000 on September 12-13, 2011.
As a manufacturer of acidified food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). You can find the Act and the acidified food regulations through links in FDA’s home page at http://www.fda.gov.
The inspection revealed that you manufacture acidified fruit and coconut gel products (Nata de Coco), and low-acid beans and purple yam in glass jars. This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Your firm’s September 29, 2011, response to the FDA-483 did not adequately address all of these deviations. We have the following remaining concerns with regard to your acidified food products:
You must manufacture acidified foods according to the scheduled process filed with the FDA as required by 21 CFR 114.80(a)(1). However, your firm failed to manufacture Coconut Gel (Nata de Coco), identified as batch # 2 (NW13 & NW14) and processed on 9/12/11, according to the filed scheduled process. Specifically, FDA observed the processing of this product and documented a cook time of b(4) that did not meet the filed scheduled process cook time of b(4). Your response failed to address how the product that was processed under these conditions was evaluated by your process authority and the final disposition of the product.
In addition, during processing, FDA observed that the b(4) of Coconut Gel (Nata de Coco) was not determined and = b(4 Specifically, a production employee measures the initial temperature (IT) at the time of capping, and then b(4) This practice does not ensure an accurate temperature measurement of the coldest jar in the batch. Your response does not address this deficiency.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. Your response should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the Current Good Manufacturing Practice regulation (21 CFR Part 110), the Acidified Foods regulation (21 CFR 114), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Priya J. Rathnam, Compliance Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Rathnam at (240) 402-2078 or via email at firstname.lastname@example.org.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition