Teva gets FDA warning for Jerusalem plant
The US Food and Drug Administration (FDA) issued the letter after an inspection at the site, which makes oral solid dosage (OSD) forms, uncovered “significant” violations from current good manufacturing practices (cGMP).
The agency said that the violations “cause your drug products to be adulterated... in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP.”
In response Teva told Reuters that it has addressed the observations and has been working with the FDA to resolve its concerns.
Citi Group analyst John Boris told the Globes newswire service that the warning would not affect drug shipments from the facility, the sale of which generates around $480m a year, or 3 per cent of the firm’s revenue.
Boris did not however that: “the FDA is withholding Abbreviated New Drug Application (ANDA) approvals associated with the Jerusalem facility until Teva resolves outstanding cGMP issues."
