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.
K D Singh Enterprises LLC, Edison, NJ
Khadag Singh/Dalbir Singh, president/vice president
In an April 8 warning letter the FDA described a Feb. 19, 2020 Foreign Supplier Verification Program inspection at K D Singh Enterprises LLC, as well as an initial inspection on Aug. 23, 2018. Inspectors found that the company was not in compliance with FSVP regulation.
FDA’s inspection resulted in issuance of an FDA Form 483a.
The significant FSVP regulation violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Wheat flour imported from (redacted).
- Spice mix imported from (redacted).
- Paneer imported from (redacted).
The full warning letter can be viewed here.
Rajshree International Inc., Downey, CA
Shubh Prasad, owner
In a May 4 warning letter the FDA described a March 6 Foreign Supplier Verification Program inspection at Rajshree International, Inc. Inspectors found that the company was not in compliance with FSVP regulation.
FDA’s inspection resulted in issuance of an FDA Form 483a.
The significant FSVP regulation violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Ying Yaang Hakka Noodles manufactured by Frumar Marketing Pvt. Ltd., India
- Lays Magic Masala manufactured by Pepsico India Holdings Pvt. Ltd., India
The full warning letter can be viewed here.
Smoked Salmon Unlimited dba H. Forman & Son, London
Lance P. Anisfeld
In a May 12 warning letter the FDA described a Feb. 13-14 inspection at Smoked Salmon Unlimited d. b. a. H. Forman & Son’s seafood processing facility. Inspectors found that the company was not in compliance with Hazard Analysis and Critical Control Point (HACCP) regulation.
FDA’s inspection resulted in issuance of an FDA Form 483a.
The significant HACCP regulation violations are as follows:
- The firm must conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, the firm’s HACCP plan for cold smoked salmon entitled “(redacted),” dated Sept. 22, 2011, does not list the food safety hazard of pathogen growth and toxin formation at the “(redacted)” critical control point (CCP). Because cold smoked salmon products are considered a raw, ready-to-eat (RTE) food, FDA recommends that they ensure that their product is maintained below 40°F (4.4°C) throughout transit.
- The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan. However, the firm did not implement the monitoring procedures at the “(redacted)” and “(redacted)” critical control point (CCP) to control Clostridium botulinum growth and toxin formation listed in their HACCP plan, entitled “Cold Smoking (USA),” for cold smoked salmon. Specifically, at the “(redacted)” CCP, their firm is not monitoring the “(redacted),” “(redacted),” and “(redacted)” to ensure their critical limits for (redacted) and (redacted) time are achieved.
When (redacted) and (redacted) critical limits are used to control C. botulinum, FDA recommends water phase salt (i.e., percent salt aqueous phase) of the finished product be a minimum of 3.5% to verify that the critical limits have been achieved. On at least five separate occasions between Sept. 26 and Nov. 28, 2019 their finished product testing results indicated the water phase salt levels of their cold smoked salmon products were below (redacted)% (between (redacted)% and (redacted)%). No corrective actions were taken in response to these results. FDA recommends that their firm ensures that no affected product entered commerce, the cause of the deviation was corrected and reassess the HACCP Plan.
At the “(redacted)” CCP, their firm is not conducting a “(redacted)” to ensure their critical limit of “(redacted)” is achieved. FDA recommends that a visual check of the recorded temperature is performed at least once per batch.
- The firm did not maintain sanitation control records for the monitoring the condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of handwashing, hand sanitizing and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic compounds; and control of employee health conditions.
- Because they chose to include a corrective action plan in their HACCP plan, their described corrective actions must be appropriate. However, their corrective action plan for their cold smoked salmon products are not appropriate at the following critical control points:
- At the “(redacted)” CCP the corrective action of “(redacted)” is not adequate to control pathogen growth and toxin formation. FDA recommends that affected products are chilled and held until a food safety evaluation of the cumulative ambient cooler temperature and time exposures are conducted.
- At the “(redacted)” CCP the corrective action is not adequate to control C. botulinum because it does not ensure that the cause of the deviation has been corrected. FDA recommends that their corrective action include making repairs or adjustments to the smoker.
The full warning letter can be viewed here.
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