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Regulatory News | 19 August 2014 | By Alexander Gaffney, RAC
For at least the 12th time since May 2013, the US Food and Drug Administration (FDA) has sent a Warning Letter to an Indian pharmaceutical manufacturer accusing it of falsifying data used to support the ongoing approval of its drug products.
For more on Indian Companies' data integrity problems, please see our updated tracker tool here.
The company, Marck Biosciencies, was subject to an October-November 2013 inspection by FDA at its Kheda, India manufacturing facility.
There, FDA said it found troubling deficiencies, including that the company generated unofficial “visual inspection records” that contained data that were "different from the official batch records reviewed by [Marck's] quality unit."
FDA said a review of those records showed that the products often contained "significantly more quality defects" than the official records indicated. For example, official records only indicated that 18 units of a drug batch failed to meet specifications, whereas the total number was actually 200. FDA said the company was unable to prove that all units had been rejected from further processing.
In other cases, FDA found Marck to be using "scratch paper" (i.e. "scrap paper") to record "critical manufacturing data." Those data did not always match the official records, FDA alleged, implying that the data were later altered to be more favorable.
"The use of unofficial and scratch paper records is not acceptable current good manufacturing practices (CGMP)," FDA wrote.
In another alarming instance, FDA said that its inspectors interviewed Marck employees who admitted that certain activities recorded as having been performed were in fact falsified, and had never been performed. "Specifically, [Marck's] head of production reported to our investigator that he completes 'in process quality assurance check' fields in the batch record but does not actually perform the listed operations," FDA wrote.
In another notable example, FDA said it found evidence that the company had "falsified documents designed to demonstrate the effectiveness of CGMP training." The company had filled out in advance the answers to an exam designed to assess knowledge of federal regulations, FDA alleged. Further, "that a senior manager was engaged in the falsification of documents is troubling and raises questions about validity of documents generated by your firm," FDA noted.
Elsewhere, FDA inspectors said they found "significant mold growth" in an on-site washroom located "at the entry of the sterile manufacturing area." The mold growth was apparently so bad that the room had partially "caved in." This was especially concerning given a recent finding by the UK's Medicines and Healthcare Products regulatory Agency (MHRA) which found fungal growth in one of the facility's parenteral products, FDA said.
Regulators also found "numerous dead insects" throughout the facility and "dead and decaying frogs" near the facility's exit dock. The facility is reportedly situated near a "swamp-like perimeter," FDA noted.
The facility was advised to implement a corrective action plan and to hire a third-party auditor to ensure organizational compliance.
FDA Warning Letter
Tags: Data Falsification, Data Integrity, Warning Letter