Contamination risk from vermin lands Indian API firm with US warning

By Dan Stanton contact

- Last updated on GMT

GettyImages/naruedom
GettyImages/naruedom
Inspectors observed birds and insects inside an API facility run by Malladi Drugs & Pharmaceuticals, according to a US FDA warning letter.

An inspection of Malladi Drugs & Pharmaceuticals’s Unit 1 in the Tamil Nadu district of India in September last year resulted in the US Food and Drug Administration (FDA) issuing a warning letter earlier this month.

The active pharmaceutical ingredient (API) maker was found to have violated current good manufacturing practice (cGMP, including failing to use appropriate precautions to minimise the risk of API contamination in an open processing area.

“Parts of your facility in which API production is conducted are open to the outdoors,” the letter​ stated. “Our investigator observed vermin, such as birds and insects, in the facility near open equipment used for drug manufacturing. Their presence puts your drugs at risk of contamination.”

The firm was also found to have issues with the use and cleaning of its equipment:

“Your cleaning processes are insufficient. You lack justification that you can prevent contamination from foreign matter and other impurities that may seep from the (b)(4). Further, your equipment is difficult to reproducibly clean,”​ the Agency said.

Problems validating the reproducibility of the firm’s API production process were also addressed in the letter:

“During our inspection, you acknowledged that you failed to adequately validate your (b)(4) API drug manufacturing process. In addition, our inspection found that your process lacked adequate control during the (b)(4) step. Twenty-four batches yielded out-of-specification test results for an unspecified impurity over approximately two years. Your firm rejected these nonconforming batches and reprocessed some of them.”

The firm, which was placed on an import alert in December, has been advised to engage with an independent consultant to assist in remediating the problems highlighted by the FDA.

Related news

Related products

show more

Accelerate your supply chain as pressures intensify

Accelerate your supply chain as pressures intensify

William Reed | 17-Sep-2018 | Technical / White Paper

Food, Drink and Non-Food manufacturers are under pressure. Range reviews, massive retail mergers, the backlash against plastic packaging and the ongoing...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

TCC TB – a new filler for direct compression

TCC TB – a new filler for direct compression

Jungbunzlauer | 09-Oct-2017 | Technical / White Paper

TCC TB is a tricalcium citrate tetrahydrate designed to function as a direct compression excipient. It combines exceptional compression characteristics,...

Related suppliers

Follow us

Products

View more

Webinars