WARNING LETTER
Rolence Ent. Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 695010
Rolence Ent. Inc.
No. 18-3, Lane 231 Pu Chung Road Taoyuan District, Taoyuan City 32083 Taiwan
Dates: July 8, 2024, through July 11, 2024
Inspection Issue(s):
Report states, “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”
These violations include, but are not limited to, the following:
- “Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm did not conduct any design validation, risk analysis, or design reviews for the Class II XR-01 Portable X-ray System, despite having shipped the product to the U.S. since 2023.”
- “Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, review of the CAPAs (19 CAPAs, from 2022 to 2024) revealed your firm did not conduct any verification/validation to ensure that such action is effective and does not adversely affect the finished device prior to implementation, and there is no documented evidence showing that your firm has implemented the proposed corrective actions.”
- “Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm has not validated the (b)(4) software (software application for X-ray quality control) used to perform the final tests of Portable X-ray Systems (i.e., tube voltage, exposure time, exposure, exposure rate, etc.) for its intended use according to an established protocol.”
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
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