The manufacturer of the Glycomat Pink Reagent Kit and the DS30 Hcy-homocysteine Test Kit was determined by the agency to have failed to establish and maintain procedures for implementing corrective and preventive actions that include requirements for analyzing sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
The letter also requested a formal meeting to discuss corrective actions, because "the violations included in this letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPA's) that warrant your immediate attention to ensure that an effective quality system is in place.
The letter also requested a formal meeting to discuss corrective actions, because "the violations included in this letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPA's) that warrant your immediate attention to ensure that an effective quality system is in place.
FDA's letter of last week, dated April 7, recounts the January observations and requests additional documentation with regard to the corrective and preventive actions taken by the Company.
The letter requested a formal meeting to discuss corrective actions, because "the violations included in this letter and discussed above concern significant deficiencies across all of your quality systems, including corrective and preventive actions (CAPAs) that warrant your immediate attention to ensure that an effective quality system is in place.
Also, the firm's corrective and preventive action procedure lacked a requirement for all corrective and preventive actions to be verified and/or validated as effective and that all corrective and preventive actions will not adversely affect the finished device.
Also, Drew failed to establish and maintain procedures for implementing corrective and preventive actions that include requirements for analyzing sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
The warning letter also noted the investigator determined that "you do not have any procedures to implement CAPA and failed to document the corrective and preventive actions taken resulting from the receipt of a complaint involving an umbilical cord clamp.
