Recipient: American Optisurgical Inc.
Product: TX1 Tissue Removal System
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 (C.F.R.), Part 820. We received your responses dated March 7, 2012 and May 29, 2012, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you at the conclusion of the inspection. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1) Failure to validate the design under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example, the Process Validation Report for the TX1 Tissue Removal Console, dated August 11, 2011 did not reference that testing was conducted in actual or simulated conditions for which the devices will used. Additionally, there was no documentation that the devices used for design validation were subjected to your required 24 hour burn in process prior to installation of the production software. Your responses, dated March 7, 2012 and May 29, 2012 are inadequate. You have not demonstrated that process validation for the TX1 Tissue Removal System has been performed under actual or simulated use condition.
Failure to validate software used as part of production 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 software that operates the (b)(4) used to fabricate and manufacture (b)(4) for the TX1 Tissue Removal System.
• The burn in software used to test the TX1 Tissue Removal Console referenced in your Process Validation Report, dated August 11, 2011.
Your responses, dated March 7, 2012 and May 29, 2012 were inadequate. You have not demonstrated that the above referenced software has been validated for its intended use.
Failure to adequately establish document control procedures, as required by 21 CFR 820.40. For example, your firm’s document control procedures, QOP-42-01) Control of Documents, Rev. D do not address how to control or identify (b)(4) used to download the software in finished devices. These. procedures do not have signature requirements that demonstrate documents, such as device history record documents· and design drawings have been approved. The documents are dated, and include the name of the individual approving the documents, but lack a signature. The software used to store the procedures, records and drawings do not have an electronic signature capability. Your firm’s controlled documents do not reference historical changes made to them. As an example, “Red Line” changes to drawings referencing component assemblies and designs used for the Tenex TX1 Tissue removal System did ·not have the date and initials or signature of the individuals conducting the “Red Line” changes to these documents. Your responses, dated March 7, 2012 and May 29, 2012 were inadequate. Your promised corrective actions have not yet been implemented.
FDA District: Los Angeles District