The FDA hit an over-the-counter drug manufacturer in South China with a Form 483 for multiple violations, including missing operating procedures.
An inspection of the Liuzhou LMZ facility revealed a lack of written procedures for facility and equipment maintenance, stability studies and non-viable particulate monitoring.
The company also failed to document that it verified its test methods, the investigators found. Specifically, it did not conduct growth promotion testing for media used in microbiological testing.
The firm also failed to include calculations for theoretical yield and actual yield in each batch record, and no action limit was defined for deviations.