Guangzhou Facility Warned for Deficient Procedures

The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility.

A May inspection revealed that the firm, which manufactures an over-the-counter topical product, marked an item used in the manufacturing process as clean despite the presence of product residue and material used in two different products.

The firm’s response was deemed inadequate as it failed to assess facility cleaning procedures or perform an evaluation of past batches for cross-contamination.

The firm also failed to follow its validation protocol, as the master batch record was missing details for a critical step, and a timer malfunction occurred during a demonstration.