WARNING LETTER
Exactech, Inc. dba Advita Ortho was issued a warning letter from the FDA.
Excerpts from a warning letter of interest to SoftwareCPR® clients.
CMS # 720250
2320 Nw 66th Ct
Gainesville, FL 32653-1630
Date of inspection July 15-25, 2025
Inspection Issues:
Quality System Regulation Violations
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.
We (FDA) address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1) Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications when deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a). For example, your firm failed to adequately establish production and process control procedures to ensure that devices conform to specifications.
Your firm’s responses are not adequate. The responses note that the root causes and contributing factors of the process control deficiencies include inconsistent enforcement of validation requirements, gaps in operator training on comparator-based inspections, and absence of formal inspection method qualification. In addition, the responses note that these deficiencies have systemic implications across your firm’s manufacturing operations and as well design transfer activities.
2) Failure to adequately establish and maintain procedures for corrective and preventative action, as required by 21 CFR 820.100(a). For example:
A. The procedure for Corrective and Preventive Actions Procedure, 701-103-137, Rev. AB, dated 6/11/2025 does not identify production events as nonconformities or quality data. A Production Event (PE) is defined as an event generated in (b)(4) utilized for processing electronic device history records, due to a deviation from pre-established product or process specifications. Production Events ((b)(4) documented events) are not analyzed as quality data sources or escalated to CAPAs where appropriate. Investigators noted that from 07/01/2023 to 7/25/2025 there was incomplete documentation maintained or available to demonstrate which Production Event entries were documented and managed as nonconformances. Additionally, no documentation was maintained or available to demonstrate that any Production Events were further assessed or analyzed as quality data sources.
B. CAPAs 2023-005 and 2025-005 addressing environmental control specifications for (b)(4) storage were verified as effective and closed, yet environmental monitoring data from March 2024 to current showed your firm continued to exceed allowable temperature and humidity limits. Temperature specifications were changed from (b)(4) to (b)(4) in June 2025 after historical data showed consistent excursions. The pFMEA for the (b)(4) Molding Process, FMEA-000445, Rev A, dated 8/1/2024, discusses product and process impact with high temperatures and humidity, and the potential failures related to air conditioning (HVAC). Specifically, the effect of high moisture in (b)(4) may impact the material strength.
Your firm’s responses are not adequate. Your firm’s responses note corrective actions under CAPA 2025-31 that include: CAPA procedural updates for verification of effectiveness; updates to Quality System’s governance and Management Review process adding additional sources of quality data (Production Events, Work in Process Scrap , environmental monitoring data, etc.); updates to software validation to include evaluation for the identification of critical to quality attributes for continuous monitoring; updates to Document Control related to the QMS process change and the determination of quality data outputs for continuous monitoring; and CAPA remediation efforts for verification of effectiveness. Your responses do not describe any retrospective review necessary to assess whether quality data such as Production Events, Work in Process Scrap, etc. or other critical to quality data attributes represent nonconformances or other quality issues that may require the initiation of a CAPA. The activities under CAPA 2025-31 along with the verification of effectiveness criteria, are in progress and extend through March 2026.
3) Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm failed to identify, document, evaluate nonconforming product including the need for investigation and notification of the persons or organizations responsible.
Your firm’s responses are not adequate. Your firm’s responses note that corrective actions under CAPA 2025-31 that included: the coordination of the nonconformance program with the Production Events (PE) and work in process (WIP), and training development. Your firm’s retrospective review of WIP and PE does not include the rationale for timeframes selected. For example, you identified July 2024 through August 2025 for retrospective review; however, FDA investigators reviewed WIP and PE data from 7/01/2023 through 7/25/2025. In addition, we disagree with your investigation that raw data and pivot tables for Production Events and WIP Scrap entries revealed that the vast majority ((b)(4)) of Production Events were benign in nature, and resolved via appropriate mechanisms (e.g. (b)(4), (b)(4) fix, and approved reworks). Additionally, it is not clear from production event logs collected during the inspection how the in process and quality control inspection failures were handled.
4) Failure to adequately establish and maintain procedures to ensure that environmental conditions do not adversely affect product quality, as required by 21 CFR 820.70(c). For example, your firm failed to adequately establish procedures to ensure your environmental controls are being maintained as specified and that your environmental control systems are adequate and functional.
5) Failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product, and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm failed to follow the procedures for Supplier Quality Management, 701-103-077, Rev AH, dated 10/31/2023. The FDA investigators noted that (b)(4)., the sole supplier of critical (b)(4) powder, has not received a required on-site audit per Supplier Quality Management Procedure Section 5, Step F, Item 2.C. The last supplier evaluation was conducted in September 2020, with no reevaluation when current procedures were implemented in October 2023. Additionally, there is no signed quality agreement as required per the procedure Section V, Step C, item 4.
6) Failure to adequately establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm failed to capture the training of employees as described in the Competency and Training Procedure, 701-103-087, Rev. AB, dated 7/9/2024. FDA inspection noted that:
A. (b)(4) employees working in manufacturing did not have required QC inspection tools documented in their training records, not meeting the requirement that employees perform all necessary training prior to task execution without oversight.
B. The procedure states that all retraining shall be documented and recorded as part of the employee’s training record. In the review of 11 nonconformance reports, 7 nonconformance reports identified operator error as the root cause. Retraining was not identified as an action item in 6 of 7 of the reports reviewed.
Your firm’s responses are not adequate. Your responses note the following activities being handled under CAPA 2025-035 include implementation of Task-Level Training Controls; development of work instructions and inspection tools; documented on the job training; the revision of Nonconforming Product Handling Procedure to enforce training; and revision of competency and training procedure. Your firm’s response does not describe any necessary training as part of the design transfer activities associated to a new manufacturing or inspection process. The activities under CAPA 2025-035 along with the verification of effectiveness criteria, are in progress and extend through April 2026.
7) Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a). For example:
A. Your firm failed to identify the correct work instructions that applies to manufacturing personnel when using (b)(4) to produce products for the Truliant Knee 02-029-190-4300 Short Headed Pin For Syringe Pin Puller, Alteon Hip 180-165-20 Alteon 6.5MM Screw, 20MM, and the Equinoxe Shoulder Torque Defining Screws. The work instructions listed did not call out for manufacturing personnel to use the Manufacturing of Product in (b)(4) Work Instruction, 701-105-1121, Rev D, effective date 2/28/2024.
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.
