Failure to Respond to Multiple FDA Requests leads to Warning Letter

Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter, dated 21 December 2023.

The company located in Singapore was registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products, including hand sanitizers. A review of import records showed multiple shipments into the United States.

In June 2022, the FDA sent a first request for records and other information to the company's contact e-mail address, which was not answered, followed by several further contact attempts. In October 2022, the company stated that no products were exported to the United States, which was in contrast to the import records.

Because the firm failed to respond to the records requests, the FDA has no indication of the level of quality assurance for the drugs manufactured at the facility. Therefore, the agency is not able to confirm compliance with Current Good Manufacturing Practice (CGMP) and other applicable requirements.

In the meantime, the registration with FDA expired and the company's consultant communicated that no shipping of drug products either directly or indirectly to the United States is planned.

For further information, please see the complete Warning Letter to Wipro Unza Singapore Private, Limited at the FDA website.