Eight citations were issued to Analytical Control Systems, Inc. in Fishers by the Food and Drug Administration (FDA) after a March 30 inspection focused on device compliance, according to data posted on the FDA’s website.
FDA records show the company received the following citations:
- ‘A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.’
- ‘Procedures for management review have not been adequately documented.’
- ‘Infrastructure requirements needed to achieve conformity to product requirements have not been adequately documented.’
- ‘One or more processes for risk management in product realization have not been adequately documented.’
- ‘Procedures for validation of processes were not adequately documented.’
- ‘Justification for not investigating a complaint(s) was not adequately documented.’
- ‘Procedures to describe the responsibilities and requirements for planning and conducting internal audits and recording and reporting audit results were not adequately documented.’
- ‘Corrective action procedures defining the requirements for evaluating the need for action to ensure that nonconformities do not recur, planning and documenting action needed and implementing such action, verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device and reviewing the effectiveness of corrective action taken have not been adequately documented.’
The FDA conducts routine inspections of facilities nationally to verify that workplaces and their products comply with agency regulations designed to safeguard public health. The findings from these inspections are made publicly available.
The FDA’s website states that the federal agency monitors the safety and quality of human and animal drugs, biological products, medical devices, and tobacco products.
Information for this article was obtained from the U.S. Food and Drug Administration. The underlying source data can be found here.
