If the company is found to be selling a misbranded product in the US, the USFDA can issue a warning letter to stop that product's import altogether, seize the whole batch of that product, get an injunction from a federal court against the company, and even start criminal prosecution that can lead to fines up to $500,000 and imprisonment of company officials for up to three years.
The inspection of Unit III of Haridwar plant of Patanjali Ayurved Limited was conducted by a USFDA investigator named Maureen A Wentzel on May 7 and May 8 last year.
"I observed that the 'Bel Sharbat' and 'Gulab Sharbat' products are sold under the PATANJALI brand name for domestic (India) and international (USA) markets, except the Indian labels have additional medicinal and dietary market claims," Wentzel said in the establishment inspection report (EIR).
The report was later shared with the company too and the PTI has accessed its copy. Patanjali Group's spokesperson did not respond to the specific queries sent by the news agency.
During inspection, in honey processing area of Patanjali's Haridwar plant, Wentzel observed that pigeons were flying above production equipment, according to the EIR.
"In the entry/manufacturing area of section...of the honey area, I observed pigeons flying above production equipment. Mr (Nitin) Jain stated that the pigeons would be removed. When production of the honey resumed on May 8, 2018, the pigeons were not in the building," she said.
Nitin Jain, Deputy General Manager - Exports, Patanjali Ayurved Limited, has been responsible for the firm's export business to the USA. During the inspection, Jain served as the interpreter for Wentzel.
She observed that in the plant, the honey was being pumped "from the finished product tank to the fillers" and the same fillers were being "used for domestic and exported honey products".
The plant also manufactures digestifs, which are post-dinner drinks that aid in digestion.
USFDA investigator wrote in its EIR that once she entered the building where digestif is manufactured, she was "informed that the firm has separate production and packaging areas for exported and domestic products".
She said while the firm's laboratory personnel and batch records "appear to follow" written operating procedures, since they were not in operation during the inspection, "I do not know if their written processing processing procedures correlate with their manufacturing procedures."
The investigator said that the export warehouse of the plant had Amla Candy and Herbal Toothpaste apart from the aforementioned two sharbats.
During the inspection, the firm was not producing any goods that were scheduled to be exported to the USA, the EIR stated.
In India, if the company is found to be selling food products with "misbranding" or "misleading claims", then a penalty of up to Rs 3 lakhs can be imposed on it under the Food Safety and Standards (FSS) Act, 2006.
The FSS Act also permits the "adjudicating officer" to ask the accountable executive in the company to take corrective actions. If corrective actions are not taken, then such "article of food" shall be destroyed, as per the law.
In 2017-18, Patanjali Ayurved Limited saw its revenue decline by 10 per cent to Rs 8,135 crore. In 2018-19, the company had posted a revenue of Rs 9,030 crore.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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