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.
The firm was also unable to identify the manufacturer of a critical raw material used in the firm’s manufacturing process and did not have proper systems to qualify raw materials.
In addition, the investigator discovered uncontrolled component release stickers on warehouse stairs and behind pallets, risking the use of unauthorized manufacturing components in the firm’s drug products.
The FDA placed the company on an import alert for automatic detention in October.