|Company:||Seco Spice Ltd.|
|Subject:||CGMP Regulation For Food/Adulterated|
|Issuer:||Denver District Office|
|Issued:||May 18, 2012||Closed:||Oct. 16, 2014|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
May 18, 2012
Ref: DEN-12-15 WL
VIA UPS Overnight Mail
Mr. Edward D. Ogaz, Owner
Seco Spice Ltd.
1808 W. Berino Rd.
Berino, New Mexico 88024
Dear Mr. Ogaz:
The U.S. Food and Drug Administration (FDA) conducted an inspection on October 31, 2011, and between November 1 and November 9, 2011, of your chili pepper and spice manufacturing facility located at 1808 W. Berino Rd., Berino, New Mexico. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. In addition, FDA investigators performed environmental sampling which identified the presence of Salmonella in your facility. Based on the finding of Salmonella and the CGMP violations, we have determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links on FDA's homepage at www.fda.gov .
Salmonella is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally vomiting.
During the inspection, FDA collected environmental samples from various locations within your firm's processing facility. Laboratory analysis of these environmental samples found Salmonella in twenty-one separate subsamples collected from processing locations. Sixteen of these positive samples were taken from locations where food is likely to be exposed. These locations were the prep/grinding room and the milling/powder room. In the prep/grinding room, positive samples were taken from the metal bar (west end) of the frame that supports a tote during filling, the exterior of the chute from auger connected to grinding machine, the metal frame of the hopper next to air lock (b)(4) and the control panel to air lock (b)(4) In the milling/powder room, positive samples were taken from the metal bar of the frame that supports totes during filling on the east facing side, as well as the exterior side of the inlet at the lower end of the auger located in the northeast portion of the room.
This was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for Salmonella . FDA investigators collected positive environmental samples during an inspection in 2009 as well. Analysis using Pulse Field Gel Electrophoresis (PFGE) showed that Salmonella isolates obtained from the FDA environmental samples collected during the 2009 inspection (specifically, on December 16, 2009) were indistinguishable by both a primary and secondary enzyme with isolates obtained during the recent inspection (specifically, on October 31, 2011). When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of Salmonella---in this case Salmonella anatum . These PFGE results suggest that Salmonella anatum may have been present throughout different periods of time at your facility and may have become established in a niche environment in your facility. This may also suggest that any new sanitation procedures you adopted after the discovery of Salmonella in 2009 were inadequate to remove this pathogenic organism, and that you must take additional corrective measures. Further, finding Salmonella in locations where food is exposed indicates a high risk of product contamination. Based on our analytical and inspection findings, we determined that your firm's products are adulterated within the meaning of Section 402(a)(4) of the Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
We received your written response on January 13, 2012, addressing the positive environmental samples that FDA reported to you on November 22, 2011 via telephone. You state that your firm has begun using a new sanitation product, and that you plan to work with a third-party consultant to prevent microbial contamination. Specifically, you plan to work with the third-party consultant to obtain a minimum of (b)(4) You state that collecting swabs on a (b)(4) basis will help protect against potential problems. FDA has concerns that this proposed corrective action is not sufficient. Please provide us any scientific information you relied upon in determining that the twelve-swab approach is appropriate so that we can evaluate that information.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulations for food, 21 CFR Part 110:
1. Your firm failed to use a water supply that is derived from an adequate source as required by 21 CFR 110.37(a). For example:
• The access port located at the top of the well head was observed to be unprotected. Further, the plastic screw cap for the access port was not completely fastened. The firm uses this access port to add chlorine directly to the well water. The water from this well is used in the wet end processing room where raw ingredients are washed and for fire suppression.
• Two outlet valves attached to the above ground well line were observed to be unprotected. This well line transfers water directly from the well to an outdoor storage tank.
We acknowledge in your written response received on January 13, 2012, you have constructed caps and covers over the open water sources around your facility. We will verify the adequacy of your corrective action during our next inspection.
2. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). Specifically, dead beetle-like insects too numerous to count were observed on totes containing product and the floor surrounding these totes. The totes contained green chile flakes and were located in the north east corner of the finished product warehouse. One live apparent larva was observed on a tote along the north wall.
We acknowledge in your written response received on January 13, 2012, you have voluntarily destroyed various dehydrated Chile peppers and inspected adjacent totes in the warehouse. We will verify the adequacy of your corrective actions during our next inspection.
3. Your firm failed to have hand-washing facilities with running water of a suitable temperature as required by 21 CFR 110.37(e). Specifically, the hand washing sink located in the powder room, grinding room, and the wet end room as well as in the employees' restrooms, did not have hot water available. The Plant Manager stated that hot water is not available at any of the employee hand washing sinks located in processing areas. Proper hand washing is needed to prevent cross-contamination and without access to a hand washing sink with water at suitable temperatures, employees may not wash their hands adequately or when necessary.
We acknowledge in your written response received on January 13, 2012, you have installed a hot water heater. We will verify the adequacy of your corrective action during our next inspection.
4. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the pedestrian door located on the east wall of the grinding/prep room and the dock door located in the southeast corner of the same room is open during evening sanitation. Bulk totes containing in-process crushed chile product are stored in this room along the southwest wall. Open pedestrian doors and dock doors allow access for dirt, debris, pests, and insects.
We acknowledge in your written response received on January 13, 2012, you have retrained your employees and installed a sign to keep the area closed. We will verify the adequacy of your corrective actions during our next inspection.
5. Your firm failed to provide a sanitary towel service or suitable hand drying devices as required by 21 CFR 110.37(e)(3). Specifically, the employee hand washing sink located in the wet end room did not have paper towels available for employees to dry their hands after washing. Maintaining hand washing sinks with disposable towels or hand drying devices increase the likelihood that employees will properly wash their hands to prevent their hands from becoming a vehicle of cross-contamination.
We acknowledge in your written response received on January 13, 2012, you have updated your Sanitation Checklist. We will verify the adequacy of your corrective action during our next inspection.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response, documentation such as environmental and product testing results for microorganisms, sanitation records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, 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 your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
LaTonya M. Mitchell
Denver District Director