USFDA observations: ‘Mosquitoes, gnats in Alkem plant; no quality control unit’
An FDA Form 483 is issued to a company’s management at the conclusion of an inspection if investigators find violations of US drug laws.
The drug regulator has also observed that the plant — owned by one of India’s largest pharma company — has “no quality control unit” at its facility. (Representational image)
A recent inspection of Alkem Laboratories Ltd’s drug facility at Daman by the United States Food and Drug Administration (USFDA) has revealed the presence of “flying insects… including mosquitoes and gnats” at the manufacturing unit. The drug regulator has also observed that the plant — owned by one of India’s largest pharma company — has “no quality control unit” at its facility.
Three USFDA investigators, who inspected the Daman facility from March 19 to March 27, observed that “buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds, insects, and other vermin”. Alkem earned around 20 per cent of its total income from the United States in 2016-17.
Explaining the observation, the investigators stated in the Form 483: “Your firm failed to establish, implement, and monitor a pest control program and procedures inside quality control areas, such as, the stability laboratory, where samples are kept and the central and (other) laboratories where all samples are stored and analysed. Flying insects, including, but not limited to, mosquitoes and gnats, were found too numerous to count in the aforementioned areas.”
An FDA Form 483 is issued to a company’s management at the conclusion of an inspection if investigators find violations of US drug laws. Alkem was issued a Form 483 with total 13 adverse observations. The company did not respond to the queries sent by The Indian Express.
However, a senior Alkem executive told The Indian Express on condition of anonymity that “Every factory has a controlled area and an uncontrolled area. Controlled area is where we do all sensitive stuff such as manufacturing, testing etc and in such areas we can’t allow an external agent such as insects as it can contaminate the medicines. Uncontrolled area consists of storage area among other things. Mosquitoes and other insects were found in the uncontrolled area.”
The investigators also stated that the company did not “investigate fungal growth on the walls” of a particular area. This fungal growth was identified in a work order dated August 28, 2016. Moreover, the investigators found that employees who are engaged in manufacturing and processing of a drug lack the training and experience required to perform the assigned functions.
The first observation in the Form 483 reads: “There is no quality control unit”. The USFDA investigators explained: “Your firm’s QC (quality control) department deleted 2,101 files since March 1, 2018, on your network…According to your Assistant Vice President of QC, your firm does not have any written procedures addressing the deletion of files from your firm’s network. No investigations were initiated for the deletion of these files.”
The investigators added that company destroyed its logbooks that are not obsolete or outdated. They also noted that the company’s quality unit failed to “track, trend and investigate invalid analytical results for system suitability”. Moreover, they found that a logbook that contained such invalid data was destroyed.
The investigators also found that the drugs were distributed to United States four months before the OOS (out-of-specification) test results were out. According to the Alkem executive, “The testing results came in November. Their concern is how will you recall the product if its test fails. We have given them ample data that these products were just shipped to warehouses in US and not to the people. And those medicines are distributed only after the test results are out. So, there is no question of recall. In case our test results fail, we will destroy that batch in the warehouse. We will give them proof of all these things.”
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