The Tarapur-based drug manufacturer of finished pharmaceuticals was cited in the warning letter for failing to record all quality activities at the time they are performed. More specifically, production employees were spotted by the US Food and Drug Administration (FDA) investigator recording final package quantities even though the operator had “not yet weighed the batch.” This type of oversight was viewed multiple times by the investigator.
In addition, at another facility in Tarapur, the firm failed to review and investigate production and quality control lab deviations. The inspection from late 2012 found there were more than 30 power outages in 2012, although the backup generator does not turn on automatically.
Despite the generator not necessarily starting up without employee intervention, Aarti “failed to conduct an investigation into the power outage’s impact on quality of product(s) being manufactured at the time.”
The FDA called on the company to “describe the source of the atypical peaks detected in the related substance assays of the batches described above and in any other API distributed to US market.”
Uptick in FDA investigations
This latest warning letter, released last week, shows the FDA’s continued persistence in cracking down on Indian manufacturers.
In June, the FDA appointed Altaf Ahmed Lal, PhD as head of the agency’s India operations. Born in Kashmir, Dr. Lal seems to recognize what he’s facing in terms of ensuring products bound for the US are safe and effective.
“A colleague recently likened my new role at FDA to scaling Mount Everest,” Dr. Lal said in a recent blog post. “But you know, I’m fond of trekking and climbing, and view this next challenge much as I do those activities, as both a challenge and an adventure.”
He added: “I want a manufacturer to ask – and be able to answer – the questions, ‘Why are we failing inspections?’ And ‘What specific controls do we still need to put into place on a 24/7 basis so that on the next FDA inspection we will pass?’ I think the answers to those questions can be found in three words: collaboration, coordination and commitment.”