As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Banjaras Inc — Sugar Land, TX

The Food and Drug Administration sent a warning letter dated Sept. 25, 2019, to President of Banjaras Inc, Sunit Kaur.

During a Foreign Supplier Verification Program (FSVP) inspection at Banjaras Inc on Aug. 21, 2017, FDA investigators found that the company was not in compliance with the requirements of federal law for their coriander and garlic and Rasam powders from foreign supplier (redacted), their Kesar mango pulp from foreign supplier (redacted), and their Suji rusk from foreign supplier (redacted). Their firm did not have FSVPs for these products.

In response to these deviations, the FDA issued an FDA 483 Inspection Form, but the agency has not received a response.

The violations noted by the FDA:

“You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:”

• “Coriander with garlic manufactured by (redacted) (e.g., entry #KM6- 3516695-2 line 21/3)”
• “Rasam powder manufactured by (redacted) (e.g., entry # KM6- 3516695-2 line 101/1) “
• “Kesar mango pulp manufactured by (redacted) (e.g., entry #KM6-3523053- 5 line 11/1)”
• “Suji rusk manufactured by (redacted) (e.g., entry #KM6-3523668-0 Line 91/2)”

A complete list of the violations can be found in the FDA’s warning letter.

Sassy Cow Creamery, LLC — Columbus, WI
The Food and Drug Administration sent a warning letter dated Dec. 04, 2019, to the owner of Sassy Cow Creamery, James Baerwolf.

In response to the recall of Bourbon Honey Pecan Ice Cream in Gluten Free Cookies N Cream ice cream containers that Sassy Cow Creamery, LLC manufactured, FDA investigators initiated an inspection at their facility from May 2, 20, and 23, 2019. FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In response to these deviations, the FDA issued an FDA 483,Inspectional Observations Form that lists deviations observed at the facility.

The violations noted by the FDA:

Allergen Controls

1. “You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2).”

“Specifically, your food allergen controls are inadequate at the packaging step to ensure that your finished food is not misbranded under section 403(w) of the Act. Your firm packaged Bourbon Honey Pecan Ice Cream into containers labeled as “Gluten Free Cookies N Cream” on February 22, 2019. This incorrect labeling caused your product to contain an undeclared tree nut allergen which resulted in a Class I Recall.”

Sanitation Controls

1. “You did not adequately implement preventive controls (i.e., sanitation controls) to provide assurances that any hazards requiring a preventive control (i.e., environmental pathogens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(3).”

“You have written procedures for sanitation (“Sanitation, Document Reference: 1-12,” last revised on January 11, 2019) and sanitation SOPs for equipment (e.g., “Ice cream Freezer – Rinse Procedure” and “Ice Cream Maker – Wash Procedure”) that serve as sanitation controls for environmental pathogens such as Listeria monocytogenes (a known or reasonably foreseeable hazard that has resulted in outbreaks of listeriosis from ice cream). You also have “Hygienic Zoning (Barrier Control)” included in “Environmental Monitoring, Document Reference 1-14,” last revised June 1, 2018, to “minimize potential environmental pathogen cross-contamination,” along with an environmental monitoring program described in the document for verification of the sanitation program. However, you did not adequately implement your sanitation procedures. Specifically:”

1. “Your sanitation procedure titled “Sanitation, Document Reference: 1-12,” last revised on January 11, 2019, states: “Documented cleaning procedures are included in the sanitation program that fully outline the methods used for specific activities and the chemicals used and their concentrations. Concentrations are verified using test kits.” You did not document verification of concentrations for the chemicals used during sanitation.”
2. “Your sanitation procedure titled “Sanitation, Document Reference: 1-12, states: “To verify the effectiveness of sanitation, a (redacted) of equipment and facility is conducted (redacted).” No (redacted) check was observed to be conducted by employees during the inspection on May 22, 23, and 29, 2019, and you are not documenting checks on production or sanitation records.”
3. “You did not implement written corrective action procedures that must be taken if the presence of an environmental pathogen is detected through environmental monitoring conducted in accordance with 117.165(a)(3), as required by 21 CFR 117.150(a), and did not document all corrective actions, as required by 21 CFR 117.150(d).”

“Specifically, your written environmental monitoring program titled “Environmental Monitoring Listeria, Document Reference: 1-14 Sub part A.1,” dated June 1, 2018, identifies corrective actions to be taken and documented when test results are “out of specification,” including “initiate an investigation to determine the source/cause,” “[p]erform a full chemical cleaning/sanitation of the area,” and “[r]esample (redacted) days.” From May 21, 2018, through December 24, 2018, you did not perform re-sampling on (redacted) days and did not document written corrective actions for any of the swabbed areas after out-of-specification Listeria spp. results were received.”

3. “You did not adequately verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring, as required by 21 CFR 117.165(a).”

“Specifically, your written environmental monitoring program titled “Environmental Monitoring Listeria, Document Reference: 1-14 Sub part A.1,” provides that swabbing for Listeria spp. will be conducted (redacted). You did not conduct environmental swabbing at the frequency required by your environmental monitoring program. As reflected in the absence of test results for these time periods, you did not conduct any environmental swabbing for Listeria spp. in the months of August 2018, October 2018, January 2019, and March 2019.”

A complete list of the violations can be found in the FDA’s warning letter.

Hindy Import Inc. — El Cajon, CA
The Food and Drug Administration sent a warning letter dated Jan. 09, 2020, to the owner of Hindy Import Inc., Kamil Hindy.

During a Foreign Supplier Verification Program (FSVP) inspection at Hindy Import Inc. on May 7,  2019 and Dec. 10, 2018, FDA investigators found that the company was not in compliance with the requirements of federal law for their dry food products such as red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, imported from Bashan Tarimsal Urun Paz San Ve Dis Tic A.S. located in Mersin, Turkey, and white quinoa imported from (redacted). The company did not have FSVPs for these products.

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations Form, but the agency has not received a response.

The violations noted by the FDA:

• “You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L for each of the following food:”

     o “bulgur coarse with vermicelli and vermicelli noodle food products imported from Bashan Tarimsal Urun Paz San Ve Dis Tic A.S. located in Mersin, Turkey”

     o “white quinoa imported from (redacted).”

“Our finding during the May 7, 2019 inspection was consistent with our finding during the previous inspection of your firm. During a December 10, 2018 inspection, we also found that your firm was not in compliance with section 805 of the FD&C Act because your firm did not develop an FSVP for the foods covered by that inspection.”

A complete list of the violations can be found in the FDA’s warning letter.

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