During an inspection conducted on March 20, 2024, the Food and Drug Administration (FDA) issued three citations to AMCO International Manufacturing & Design, Inc. in Brooklyn for device compliance violations, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The design history file does not demonstrate that the design was developed following the approved design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820.’
- ‘Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.’
- ‘Equipment calibrations, checks and maintenance activities have not been documented.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
