Mosquitoes, gnats in Plant; no quality control: USFDA investigators Observe on Alkem Plant

New Delhi: The USFDA investigators has found mosquitoes and gnats in the manufacturing unit of Alkem Laboratories Ltd at Daman during a recent inspection and also observed that the plant does not have any quality control unit in its facility, according to a recent report in Indian Express.

Daman facility of Alkem has been inspected by the three investigators of USFDA from March 19 to March 27.

As per the news report, the investigators have 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”.

FDA has issued a Form 483 with total 13 adverse observations to Alkem.

Explaining the observation, investigators has 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.”

A senior Alkem executive told The Indian Express, “Every factory has a controlled area and an uncontrolled area. A 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. The uncontrolled area consists of storage area among other things. Mosquitoes and other insects were found in the uncontrolled area.”

According to the daily, 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. The investigators have also found that employees who are engaged in manufacturing and processing of a drug lack the training and experience required performing the assigned functions.

the first observation in the Form 483 reads as “There is no quality control unit” and the investigators have 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 company is alleged to have destroyed its logbooks that are not obsolete or outdated and contained invalid data. At the same time, the company’s quality unit failed to “track, trend and investigate invalid analytical results for system suitability”.

The investigators also found that the drugs were distributed to United States four months before the OOS (out-of-specification) test results were out.

Alkem executive told Indian express, “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.”