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DIVI's LABS gets USFDA FORM 483

Following inspection of Unit-2 at Vishakhapatnam for API manufacturing, USFDA has found more problems at Divi’s Laboratories Limited that was earlier banned from shipping to the US in March 2017.

The inspection was conducted for full cGMP and verification of all corrective actions proposed against the previous inspection observations; however, all previous observations were confirmed and resolved.

The new appointed inspection team from USFDA conducted a fresh inspection and issued Form 483 detailing 6 problems. Divi’s laboratories confirmed this inspection as ‘procedural’ and released an action plan to be implemented to address these problems in given stipulated time.

Earlier the Unit-2 facility was imposed with import ban on March 2017. At that time, the alert was issued under clauses 66-40 and 99-32 of US Food and Drug Administration (USFDA) regulations.

A 66-40 import alert is issued when “inspection has revealed that a firm is not operating in conformity with current Good Manufacturing Practices”.

A 99-32 import alert is issued to firm that have either refused to “permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel.”

Meanwhile, DIVI Laboratories said that Ireland’s HPRA and Slovania’s JAZMP who audited the site made no critical observations.

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