The FDA cited three devicemakers for a variety of deficiencies including quality and complaint procedures and equipment problems.
Trinity Sterile: Trinity Sterile was cited for lack of quality audits, equipment maintenance, and incomplete device history records.
The agency issued a Form 483 after a February-March inspection of the firm’s Salisbury, Md., facility. Investigators found the company did not sufficiently detail the maintenance process for several pieces of equipment and machinery, including sealing machines, HVACs and air compressors, boilers and sterilizers.
The agency also found 18 of 40 2015 audit “elements” where the audit was left incomplete, and none of the 2016/2017 audits were closed.
The company’s machine validation protocols lacked clearly-defined acceptance criteria for validating all five machines in manufacturing, and test failures occurred in three of the five without justification. In its CAPAs for nonconforming products, the company failed to create a noncomformance form or determine the root cause, which the agency noted as a repeat observation.
The devicemaker had no design control procedures for its convenience kit products relating to expiration dates, defined user needs and intended uses, or risk analysis for packing or life expectancy. Eleven of 15 CAPAs did not identify a root cause, check for effectiveness or perform corrective actions.
Saginaw Medical Services: Saginaw Medical Services drew a Form 483 for the absence of quality and acceptance procedures as well as its failure to maintain device records.
The agency issued the form after a May inspection of the firm’s Saginaw, Mich., facility. According to investigators, the facility had no procedures or directions in place regarding its quality policy, management reviews or audits, and did not conduct regular audits. The company had completed several made-to-order wheelchair cushion jobs since the beginning of 2015, but had no documentation describing the production procedures.
The firm also failed to produce documentation of the acceptance activity for the cushions’ final fitting process or procedures for this activity, the agency said. Investigators found the firm’s complaint procedures did not include an evaluation process for whether a complaint is reportable as an MDR. It also lacked device master records or device history records for the cushions.
Lantz Medical: The FDA put Lantz Medical on notice for issues ranging from undefined complaint procedures to a lack of procedures for device history records.
The agency issued a Form 483 following a May inspection of the firm’s Indianapolis facility. Inspectors found the company had no requirements for analyzing whether complaints warrant investigations. Lantz also lacked procedures for evaluating complaints to determine whether they must be reported to the FDA as an MDR, and it had no procedures for MDR submissions.
Investigators also highlighted Lantz’s CAPA procedures, noting they did not require analysis of quality data for the company’s Vector I Hand Rehabilitation System. The company also had insufficient procedures for ensuring conformance and design control, receiving or inspecting components, or maintaining device history records.
Lantz lacked procedures for selecting suppliers or for performing quality audits. The company also failed to document management reviews from June of 2014 to May 2017. The facility’s document control procedures did not require changes to be approved before implementation.