| Public Health Service Food and Drug Administration |
| Denver District Office Building 20 - Denver Federal Center P.O. Box 25087 Denver, Colorado 80225-0087 TELEPHONE: 303-236-3000 |
Department of Health and Human ServicesApril 26, 2010
WARNING LETTER
VIA UPS PRIORITY
John R. Montoya, President/Co-Owner
La Estrellita Enterprises, Inc.
dba La Estrellita Salsa Company
436 W. 915t Circle
Thornton, CO 80260
Ref: # DEN-10-11-WL
Dear Mr. Montoya:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, La Estrellita Enterprises, Inc. (dba La Estrellita Salsa Company), located at 45 North Main Street, Brighton, Colorado, 80601, on February 18 - 26, 2010. The inspection revealed that you have serious deviations from the Acidified Food regulations [21 Code of Federal Regulations (CFR) Parts 108 and 114]. Failure to comply with all of the requirements of 2l CFR 108.25 and the mandatory portions of part 114 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Federal Food, Drug and Cosmetic Act (the Act). In addition, such failure renders your Acidified Food adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Accordingly your firm's acidified food products including your Red Salsa, Hot Green Jalapeno Salsa, and Green Vegetarian Chili products have been packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
We acknowledge receipt of your firm's response to the FDA 483 received on March 19, 2010 and-our comments are included below. We will verify the effectiveness of the your indicated corrections during the next inspection.
The significant violations documented during the inspection include, but are not limited to, the following:
1. Your firm did not employ appropriate quality control procedures to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a). Specifically, the pH meter that your firm uses to determine product pH was not standardized with the appropriate pH buffer (pH 4.0) prior to use in determining product pH. Procedures for standardization of pH meters and product pH measurement can be found in 21 CFR 114.90. You indicate in your response that you now have the pH 4.0 buffer. We will verify the adequacy of your product pH measurements during the next inspection.
2. 21 CFR 108.25(c)(1) requires that a commercial processor engaged in the manufacture, processing or packing of acidified foods, register and file information with FDA including the name of the establishment, principal place of business, the location of each establishment in which processing is carried on, the processing method in terms of acidity and pH control and a list of foods so processed in each establishment. However, your firm, which manufactures acidified foods, has not registered with FDA in accordance with 21 CFR 108.25(c)(1). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://ww.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/
As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, your firm has failed to file a scheduled process for the following acidified foods that your firm manufactures: Vegetarian Green Chile (Hot, Medium, and Mild versions), Red Salsa (Hot, Medium, and Mild versions); and Hot Green Jalapeno Salsa.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.fda.gov/Food/FoodSafety/ProductSpecificInformation/AcidifiedLow-AcidCannedFoods/
3. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, no scheduled process has been established in accordance with the requirements of 21 CFR 114.83 for the following acidified foods:
a. Green Vegetarian Chile (Hot, Medium, and Mild versions)
b. Hot Green Jalapeno Salsa
c. Red Salsa (Hot, Medium, and Mild versions)
Your response indicates you planned to meet and discuss your products on 3/19/10 with (b)(4),(b)(6). You will need to obtain the appropriate processing information and register and file processing information with FDA as indicated above for all products that you manufacture that are determined to be acidified foods.
4. Your firm failed to maintain production records of examination of raw materials, packaging materials, finished products, and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels as required by 21 CFR 114.100(a) and 21 CFR 114.100(d). Specifically: No records are maintained documenting examination of raw materials, packaging materials, or finished product evaluations.
We note that your response indicated that you are now adding this to your records requirements. We will verify the adequacy of the above records to comply with the requirements of 21 CFR 114.100(a) and (d) during the next inspection.
5. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces to comply with 21 CFR 110.35(a) and 110.35(b). For example:
a. During cleaning of production equipment, piping between the kettle and filler were not broken down to assure removal of all food debris and burn on residue. In addition, the bottom of the (b)(4) fill reservoir was not broken down to remove build-up of heavy food residue although manufacturer's instructions require break-down as often as necessary to remove food debris.
b. Your chlorine-based sanitizer used to sanitized equipment before use has been determined during at least two of the past three inspections to contain chlorine at a concentration over 200 parts per million (ppm), which could cause the residue to become a food contaminant.
On other occasions during our inspection, your chlorine-based sanitizer measured at 10 ppm. Sanitizing solution with a sanitizer concentration below manufacturer's label recommendations may prevent removal of micro-organisms of a public health concern.
We note that your response indicated, concerning chlorine measurement, that you are now measuring 80 ppm chlorine in the sanitizer. We will verify the adequacy of your sanitizer chlorine concentrations during the next inspection.
6. Your firm has not prepared and maintained current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing and controlling products, determining the effectiveness of recalls, notifying FDA, and implementing recall programs to comply with 21 CFR 108.25(e). Specifically, you have not developed a formal recall procedure to identify products that may be injurious to health: You also fail to maintain records that identify initial distribution of finished product in the event your firm needs to conduct a recall.
We note that your response indicated that you are now recording which batches go to each distributor. We will verify the adequacy of the above records in meeting the requirements of 21 CFR 108.25(e) during the next inspection.
We acknowledge receipt of your written response to the FDA-483, list of inspectional observations, issued to you at the close of the recent inspection. However, though the response appears to address our concerns, it is inadequate in that you have not provided documentation to confirm the steps you have taken or are taking to correct the deficiencies. For example, you have not provided pictures of repaired floor tiles or payment receipts to service persons; copies of monitoring records showing cleaning of piping or temperature achieved during processing of acidified products; and/or a receipt showing the purchase of pH 4.0 buffer. Further, you have made commitments to correct the deficiencies noted in this Warning Letter during past inspections and meetings, but you have failed to follow through with the appropriate corrective action.
We acknowledge corrective actions were taken to some noted deficiencies at the time of the inspection, including but not limited to, restoration of running water in restrooms and removal of unused equipment and debris from the side of the walk-in freezer.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations (specifically 21 CFR Parts 110 and 114).
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Your written response should be directed to the U.S. food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Schmidt at (303) 236-3046.
Sincerely,
/s/
H. Thomas Warwick, Jr.
Denver District Director
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