Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

Bingbing Pharmaceutical, Shiyan Shi Hubei Sheng, China (10/3): FDA inspected the firm in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch. The company also failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Additionally, its quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with GMPs. To view the letter, click here.