Two Indian API Manufacturers Refuse FDA Inspection
According to the US FDA, two Indian manufacturing facilities have been added to the Red List of foreign firms that are now banned from shipping product to the US. Cheryl Laboratories, Mumbai, producing active pharmaceutical ingredients (APIs) and Phalanx Laboratories, Visakhapatnam, producing APIs and intermediates both refused FDA inspections without giving any comment.
The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.
- Cheryl Laboratories has produced creams, ointments, gels and aseptic solutions since 2004
- Phalanx Laboratories advertises the use of a quality management system complying with ISO 9001-2008, that its facility was accredited by Japanese regulators and that their APIs and intermediates comply with the regulatory requirements of various prominent international regulatory bodies, including Europe and U.S.
However, the two manufacturers are now called for action to get off the list.
FDA: Import Alert - Red List