Inspections, Compliance, Enforcement, and Criminal Investigations
Ram Precision Industries, Inc. 17-Oct-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
October 17, 2005
VIA FEDERAL EXPRESS
Rick A. Mount
Ram Precision Industries, Inc .
11125 Yankee Road
Centerville, OH 45458-3580
Dear Mr. Mount:
An inspection of your medical device manufacturing firm located in Centerville, OH conducted by our investigator on August 16-18 and 30, 2005, revealed that your firm manufactures implantable devices, such as bone screws and spinal cages. These are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. 321).
Your 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The deviations from the QSR include, but are not limited
to, the following:
Production and Process Controls
1. Failure to have written procedures for the acceptance/rejection of finished devices; and failure to document finished device testing activities, as required by 21 CFR 820.80(d). Specifically, of the 17 device history records reviewed by the FDA investigator, 11 did not have the finished device testing documented; and 12 did not have a stock accepted tag completed.
2. Failure to document the rework and finished device testing performed on the 85 temporary tack devices that were made under work order #006893-001, as required by 21 CFR 820.90(b)(2).
3. Failure to perform preventive maintenance and to establish written equipment maintenance schedules for the adjustment, cleaning and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1 & 2). Specifically, the required weekly and monthly preventive maintenance checks on the [redacted] fabricating machine are not being performed; and there are no written procedures describing what checks/maintenance needs to be performed.
4. Failure to develop a complete Device Master Record (DMR) for implants that are manufactured by your firm, as required by 21 CFR 820.181. Specifically, your firm has not developed a DMR that contains or refers to the location of the specifications (i.e., drawings), production process specifications (i. e., manufacturing equipment specifications), quality assurance procedures and specifications (i.e., finished device testing criteria), and packaging and labeling specifications for the medical devices that you contract manufacture.
5. Your "Control of Nonconforming Product" procedure is incomplete in that it does not require the red reject tag that your firm completes when devices fail finished device testing be retained. [21 CFR 820.90]
Corrective and Preventive Actions
6. Failure to document corrective and preventive activities, including analysis of quality data sources, investigations of causes of nonconformances, implementation of corrective and preventive actions, and verification that the corrective action is effective, as required by 21 CFR 820.100(b). Specifically:
Eight of seventeen Non-Conforming Material Report forms were inadequate in that: five of the report forms did not describe in detail the corrective action and did not verify the corrective action was effective (#2898, 3060, 3061, 3074, and 3123); two did not describe why the report forms were "Logged in Error" (#3022 and 3023); and one did not document the root cause and the corrective action taken (#2991).
Two of the four Corrective Action Requests (CAR 709 and 717) did not verify that the corrective action was effective; and one Corrective Action Request (CAR 703) could not be found.
7. Failure to address in the "Corrective Action" procedure, "Preventive Action" procedure and/or the "Analysis of Data" procedure how your firm will analyze (trend) processes, work operations, quality audit reports, complaints and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; and what statistical methodology will be used. [21 CFR 820.100(a)(1)]
8. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained, as required by 21 CFR 820.20. For example:
Quality system procedures have not been established . [21 CFR 820.20(e)] For example, there are no written acceptance procedures, calibration procedures, maintenance procedures, and training procedures.
9. Failure to develop training procedures and to adequately train personnel to perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, the review of a manufacturing area employee's training records did not contain records to show that s/he has been trained on the quality system regulations.
You should know that these are serious violations of the law. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or civil penalties.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As president of Ram Precision Industries, Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these deficiencies. In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe