Marck Biosciences Ltd, Gujarat-based manufacturer and marketer of sterile dosages, on Friday expressed “surprise” over the United States Food and Drug Administration (USFDA) issuing a warning for alleged violations of current good manufacturing practices (CGMP) regulations for finished pharmaceuticals at the company’s plant at Kheda in the State.

In a statement here, Bhavesh Patel, Managing Director of Marck Biosciences (now Amanta Healthcare), said the USFDA had inspected the company’s facilities in October 2013 and made 18 observations, including on various aspects of documentation and maintenance of records as well as issues outside the facility.

Subsequently, the company’s corrective action plan and compliances were submitted to the USFDA within the stipulated 21 working days in November 2013, he said.

The USFDA also issued an import alert for the company’s products manufactured at Kheda.

Referring to the notification of a warning by the USFDA now, Patel said it did not take into account the compliance filings by Marck. “We are surprised that USFDA has issued a warning letter well after all compliance was completed and validated by subsequent inspections, including those by the UK’s MHRA and SGS Malaysia.”

“The warning letter is clearly the result of an unfortunate miss in taking into account all the documentation, supporting information and comprehensive and substantive clarifications and corrective measures where required. We are also quite puzzled as to why the US FDA has issued this letter nine months after there was filing of our response and completion of compliance which was subsequently validated by inspections undertaken by the health authorities of other countries.”

Patel pointed out that the facility has been certified by MCC South Africa, TGA Australia, MCAZ Zimbabwe, MHRA (UK), SGS (Malaysia) and SGS India. Also, he said Marck Biosciences did not export to the US markets.

“The USFDA had, as a matter of practice, shared this report with the UK’s MHRA, whose two-member team spent five days at our site and were satisfied with our compliances. The UKMHRA team had also met the commissioner of Gujarat FDA before and after inspection and expressed their satisfaction.”

Patel said there is also absence of significant detail and lack of clarity in the points raised by the USFDA. The reference of the USFDA to frogs, rodents and insects are related to observations made at the construction site adjacent to the plant and not within the plant site. This has not impacted the integrity, safety and hygiene standards of the facility. Further, subsequent inspections by other authorities have not revealed any lacunae in data integrity.

Marck Biosciences Ltd. had rebranded itself as Amanta Healthcare as part of the company’s requirement to reposition itself in view of its forthcoming products and expansion, he added.

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