API firm Unimark Remedies warned by US FDA about Indian plants
The US regulator detailed its concerns about Unimark in a warning letter this week, explaining that inspectors who visited the facilities in May and August 2015 observed a number of deviations from current good manufacturing practice (cGMP) standards.
At the Vapi site, the agency found evidence Unimark had failed to investigate out-of-spec test results and had changed active pharmaceutical ingredient (API) production process without assessing the impact of doing so.
Meanwhile, inspectors who visited the Bavla site saw “dirt and birds in the manufacturing area” and “a lizard in the controlled-processing area” according to the letter.
They also criticized Unimark for failing to document out-of-spec results, ensure that testing procedures were scientifically sound and poor staff training at the Bavla facility.
The warning letter is the second the US Food and Drug Administration (FDA) has sent to Unimark in 12 months.
Last September, the agency criticized operations at the Bavla site, citing a failure to document production and analytical testing activities.
Jordanian drug manufacturer Hikma recently sold a minority stake in Unimark that it acquired in 2011 for $33m (€29.2m). The sale was a condition of Hikma's acquisition of Roxane Laboratories.
A Hikma spokeswoman told us "we don’t disclose information regarding our suppliers" when we asked in the firm bought APIs from Unimark.