USFDA presses import restrictions on Wockhardts Chikalthana plant
The USFDA has imposed import restrictions on Chikalthan manufacturing plant of drug major Wockhardt due to non-compliance with good manufacturing practices (GMP). While this had been in discussion for quite some time, this import alert invariably means a ban on the plant. This is the company’s second manufacturing plant to face the heat of USFDA. Also, in the last month, the Chikalthana facility was hot by the UK health regulator due to deficiencies in good manufacturing practices
The information about this import alert has also been posted on the USFDA website, which mentions about the ban on the manufacturing unit of L1, at Chikalthana, Aurangabad, Maharashtra. An import alert means the drugs and medicinal products manufactured at the site face detention without physical examination. Such firms and their products are considered to not have met the good manufacturing practices (GMP).
Earlier the Waluj facility of the company has been under the FDA scanner and had faced similar import alert, although five products were excluded. Recently, Wockhardt’s Nani Daman facility, in Gujarat also faced restrictions on import of medicines due to violation of GMP standards. The company stated that it had received warning letter for its facilities at Chikalthana and Waluj.