From the FDA Letter:
During an inspection of your establishment located in Naples, FLon November 4, 2015 through November 6, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures A/C Powered Illuminators. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
These violations include, but are not limited to, the following:
1. Failure to adequately establish procedures for corrective and preventive actions (CAPA) as required by 21 CFR 820.100(a). Specifically, your firm conducted CAPA activities related to spot uniformity and homogeneity of your fiber optic cable illumination and misalignment of your Isovu Headlight Camera System in March 2011. The records for these CAPAs did not include documentation related to your investigation into underlying causes and verification or validation of the corrective action.
This is a continued observation from previous inspections of your firm in January 2010 and August 2005.
2. Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, Section 4.2 of your Quality System Regulation Manual (QSRM) outlines your purchasing controls. Your firm did not implement these procedures to adequately qualify the new supplier of your fiber optic cables in 2011.
This is a continued observation from previous inspections of your firm in January 2010 and August 2005.
3. Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm relies on your suppliers’ Certificates of Analysis and a UL certification for incoming products. These activities do not ensure that these incoming products meet your product specifications.
4. Failure to establish and maintain procedures for design change, as required by 21 CFR 820.30(i). Specifically, Section 2 of your QSRM outlines your firm’s procedures for design change. These procedures do not include requirements for the identification, documentation, validation or verification, and approval of design changes prior to implementation.
5. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). Specifically, your firm has not established a DHF for your 1180 XSB Xenon Light Source devices to demonstrate that the design was developed in accordance with an approved design plan. Additionally, a review of your DHF did not include documented evidence that the design was approved for transfer into production.
We acknowledge receipt of your response on December 1, 2015 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, issued to your firm on November 6, 2015. Your response did not provide adequate supporting evidence that the referenced corrections and planned courses of action have been implemented.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm482382.htm
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