A Hong Kong API distributor has received a Warning Letter from the US FDA after failing to have a Quality Unit and incorrectly labelling products.
cbsCHEM’s active pharmaceutical ingredient (API) plant in Hong Kong and its US pharmaceutical labeler/relabeler facility in Tempe, Arizona, fall under the warning following inspections undertaken by the US Food and Drug Administration (FDA) in April and June 2013.
“During the inspection, you stated you did not have a quality unit, provided no written documents describing the roles and responsibilities of a Quality Unit, and had no written procedures for quality activities,” the letter stated in regards to the Hong Kong site, and though cbsCHEM had responded to initial criticisms from the agency’s visit, not enough detail was provided.
The plant was also subject to failings in maintaining complete records of APIs, transferring quality and regulatory information to customers, and controlling the API repackaging and relabeling operations.
For the latter, the “practice of storing unlabelled APIs inside inadequately labelled totes can lead to mix-ups,” the FDA said, whilst the facility was also chastised for storing returned APIs on the same shelves, without clear separation or identification.
As for the Tempe plant, the FDA criticised the failure to relabel and hold APIs under appropriate cGMP controls and the failure to maintain complete records.
The firm manufactures and distributes a number of APIs, but the Hong Kong facility has been hit by a couple of US Import Alerts. In 2012, the FDA banned Sildenafil Citrate – the API found in Viagra – made at the plant from being imported to the US, because they did not meet labelling requirements.
A number of other APIs made at the facility fell under another import alert last year, after failing to meet GMP standards.