Devices

Diasol Gets 3rd Warning Letter in October

David McFarland

— 2 min read
Share

In what may be a targeted inspection crackdown by FDA, Diasol has been issued its third Warning Letter this month, with each letter addressing deficiencies at a different facility. The latest Warning follows a 6/6-6/21 agency inspection at the firm’s facility in San Fernando, CA, that manufactures liquid and powder sodium bicarbonate products for use in hemodialysis systems. The unusually long letter says that specific Quality System and Medical Device Reporting regulation violations were: 

  •          failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
  •          failing to establish and maintain a device history file for each type of device;
  •          failing to establish and maintain procedures for verifying the device design to confirm that the device output meets the design input requirements;
  •          failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
  •          failing to maintain a complete device master record;
  •          failing to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
  •          failing to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as well as failing to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met;
  •          failing to establish and maintain procedures for implementing corrective and preventive action;
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          failing to establish and maintain procedures to control product that does not conform to specified requirements;
  •          failing to evaluate and select potential suppliers, contractors, and consultants based on their ability to meet specified requirements;
  •          failing to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained;
  • ·        failing to establish procedures to identify training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities and maintain documentation of training;
  •          failing to establish and maintain procedures to control all required documents;
  •          failing to establish procedures for quality audits; and
  •          failing to develop, maintain, and implement written Medical Device Reporting procedures.

Earlier this month, FDA Warning Letters addressed deficiencies at Diasol facilities in Watertown, TN, and Phillipsburg, NJ. The California Warning Letter references those two along with a 2010 Warning Letter on facilities in San Fernando, CA, and Phoenix, AZ. That letter was followed by a 2011 regulatory meeting at the agency’s Los Angeles District Office when the firm’s responses to the Warning Letter were found to be inadequate. Responses to the current San Fernando letter also were generally inadequate, FDA says. “Based upon the regulatory history of your firm and the recently observed widespread deficiencies,” the letter says, “we are concerned about your ability to make appropriate, corporate-wide systemic corrections that are sustainable over time.”

Diasol was told to take prompt actions to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, documentation of the steps, and a timetable for completion.

Read more