WARNING LETTER
Pulido Associates, Inc MARCS-CMS 527340 —
- Recipient:
- Pulido Associates, Inc
United States
- Issuing Office:
- Center for Tobacco Products
United States
| |
Dallas District Office 4040 North Central Expressway Suite 300 Dallas, Texas 75204 |
May 08, 2017
2017-DAL-WL-17
Warning Letter
UPS OVERNIGHT MAIL
Robert Pulido Sr., President and Owner
Pulido Associates, Inc.
7601 Benbrook Parkway
Benbrook, Texas 76126
Dear Mr. Pulido:
Between the dates of December 14, 2016 to December 16, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 7601 Benbrook Parkway, Benbrook, Texas 76126, where you manufacture acidified products. 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 108), Part 114, Acidified Foods (21 CFR Part 114) and Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110). 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 it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through the link in FDA’s home page at http://www.fda.gov. The FDA has not received a written response from your firm concerning the FDA 483, Inspectional Observations, which was issued to your firm at the conclusion of your inspection on December 16, 2016.
As an acidified food processor, you are required to comply with the Act and the federal regulations related 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 B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
During our inspection, we observed the following significant violations:
1. As a commercial processor engaged in the thermal processing of acidified foods you must no 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 manufactured and distributed acidified foods such as Pulido’s Red Salsa (Picante), Tomatillo Salsa, Gringo Salsa and Salsa Casera without a scheduled process being filed with the FDA.
Further, your firm could not provide a scheduled process to the FDA for any new acidified product in all container sizes of acidified foods, as required by 108.25(c)(1). Also, your firm’s Acidified Food Registration is currently canceled under FCE 03875 and you have no individual process filings with the FDA. Scheduled process information for Acidified Food products must be submitted on Form FDA 2541e (Process Filing for Acidified Method). More information on filing can be found in the publication Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods at the following hyperlink:www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007437.htm
2. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge, as required by 21 CFR 114.83. Specifically, your firm does not have a scheduled process for Pulido’s Red Salsa (Picante), Tomatillo Salsa, Gringo Salsa and Salsa Casera in any size or container your firm produces and distributes.
3. Instruments used for measuring conditions that control or prevent the growth of microorganisms must be adequately maintained, to comply with 21 CFR 110.40(f). Specifically, during the inspection, you did not have any records of your pH meter calibration used to conduct finished equilibrium pH testing. Furthermore, your firm is only using a single buffer of pH 4.1 solution to calibrate your pH meter every three months.
4. Your firm failed to prepare a recall procedure and maintain recall records, as required by 21 CFR 108.25(e). Specifically, your firm could not produce any files or a recall procedure during this FDA inspection. To date, your firm has not supplied a response or any evidence containing a draft of your recall procedure. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
5. Your firm failed to apply any manufacturing coding, as required by 21 CFR 114.80(b). Specifically, your firm does not apply a manufacturing code to the acidified product Tomatillo Salsa and Salsa Fresca packaged in a 16 ounce bottle. Each container of product should contain an identifying code permanently visible to the naked eye.
6. Your firm failed to maintain equipment so as to facilitate cleaning of the equipment, as required in 21 CFR 110.40(a). Specifically, you have a ripped and worn fabric covering over the chute of your corn dispenser. This worn fabric covering can introduce foreign materials and other contaminants into your acidified food product. Furthermore, you have a rubber mat on the outlet of the corn grinder, a food contact surface, with observed filth build up that may be introduced into finished product.
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 and the products that you manufacture are in compliance with all requirements of the Act and federal regulations. It is your responsibility to review all products that you manufacture and distribute commercially to determine if they are subject to the acidified foods regulations (21 CFR 114). You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
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 the re-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 of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to S. Alexander Hamblin, Compliance Officer, U.S. Food and Drug Administration, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact S. Alexander Hamblin at 214-253-5240.
Sincerely,
/S/
Shari J. Shambaugh
Acting Dallas District Director