FDA Slaps BioLab-St. Joseph With Warning Letter
Puerto Rican devicemaker BioLab-St. Joseph received an FDA warning letter for a host of cGMP violations, including CAPA procedures.
Following an Aug. 6 to 27, 2014, inspection of the devicemaker’s Bayamon, P.R. facility, FDA investigators cited the firm for failing to establish and maintain procedures for implementing corrective and preventive actions. Additionally, the firm lacked quality audit mechanisms to ensure compliance and evaluate system effectiveness, the March 18 warning letter states.
The company’s Sept. 16, 2014, response did not detail any revised procedures, including newly implemented data quality measures, or offer evidence that employees would be trained on the revised procedures, the letter states.
BioLab-St. Joseph failed to ensure that its manufacturing processes consistently delivered sterile cultures as specified and lacked documented evidence that supported its process. Specifically, the company didn’t control environmental conditions to ensure product quality and protect against contamination.
The FDA also chides the company for not ensuring that all purchased or received products and services met specifications. For example, the devicemaker failed to establish and maintain procedures for acceptance of incoming products.
In addition, BioLab-St. Joseph failed to record customer complaint investigations involving a defective device and provide evidence of corrective action.
The FDA also dinged the company for introducing several devices into commercial distribution without premarket approval. The company declined to comment. — Jason Scott