Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204-3128
September 17, 2015
UPS OVERNIGHT MAIL
Ruby E. Reeve, Owner
Ruby's Quail Farm
142 Arapaho Drive
Gordonville, Texas 76245
Dear Ms. Reeve:
On May 14 to 21, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 142 Arapaho Drive, Gordonville, Texas, where you manufacture acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 1 08) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart 8, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
During our inspection, we observed the following significant violations:
1. 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 the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, 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).
Specifically, your firm has failed to file scheduled processes accepted by FDA for the Hot and Mild Pickled Quail Eggs in a pickling brine solution of vinegar and water packed in the volume of (b)(4) glass jar size (net weight of the content is labeled as 13.5-oz or 383 grams).
We acknowledge that your firm initially submitted a scheduled process for the (b)(4) container size on (b)(4), but it was deemed incomplete and returned to your firm on (b)(4) for your correction. Your firm has been manufacturing the acidified food packed in the (b)(4) container sizes since (b)(4) but does not have a filed scheduled process for each acidified food (hot and mild flavors) accepted by FDA.
Scheduled process information for acidified foods much 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/FoodSafetyProductSpecificlnformation/AcidifiedLowAcidCannedFoods/default.htm.
2. Your firm failed to follow a scheduled process used to manufacture acidified foods, as required by 21 CFR 114.80(a)(1).
Specifically, your firm did not adhere to its scheduled process for the Hot and Mild Pickled Quail Eggs used to manufacture several batches of these acidified foods packed in the (b)(4) volume of glass jars by failing to verify and record the correct process (b)(4) temperature in the batch records to ensure a safe product. For example, the batch records for Batch (b)(4) and (b)(4) were recorded with an incorrect process (b)(4) temperature of (b)(4), which was below the minimum scheduled process temperature of (b)(4).
3. Your firm failed to maintain processing and production records showing adherence to the scheduled process, including records of pH measurement and critical factors intended to ensure a safe product, as required by 21 CFR 114.100(b). Specifically:
a) Your batch record for Batch (b)(4) of the Hot and Mild Pickled Quail Eggs processed on May 6, 2015 did not record the test results of the equilibrium pH of the solid portion and liquid portion of these acidified foods.
b) Your batch record for Batch (b)(4) of the Hot and Mild Pickled Quail Eggs processed on April 7, 2015 did not record the (b)(4) temperature of the thermal process.
c) Your batch records for (b)(4) batches of the Hot and Mild Pickled Quail Eggs processed in 2013 did not record the process time of the (b)(4) temperature (i.e., see batch records for Batch (b)(4)).
4. Your firm failed to maintain records that identify initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use, as required by 21 CFR 114.100(d).
Specifically, your firm did not always document the delivery dates of the acidified foods to each customer as required by your "Customer Product Delivery Batch Numbers" record. For example, your firm distributed a number of batches of the Hot and Mild Pickled Quail Eggs to (b)(4) customers on or after May 7, 2015 without documenting the delivery dates.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting there-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long-term corrective actions, 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 corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Ta at (214) 253-5217.
Reynaldo R. Rodriguez, Jr.
Dallas District Director