Hong Kong Drugmaker Warned for Quality Control, Procedural Shortcomings

Wong Lap Kwong Medicine Company drew a warning from the FDA for failing to identify active pharmaceutical ingredients and to establish procedures for numerous basic functions in its Hong Kong facility.

The agency’s September inspection of the facility revealed that the firm did not conduct identity tests for an active pharmaceutical ingredient prior to the manufacturing of an over-the-counter drug product. In addition, the company relied on suppliers’ certificates of analysis instead of qualifying them first.

The facility also did not have adequate written procedures for many basic drug manufacturing functions, including: customer complaint handling; recalls; annual product reviews; out-of-specification/deviation investigations; issuing and documenting batch records and reviews; training for current good manufacturing practices; cleaning; storage conditions; and change control.