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LAR MFG., LLC 09/12/2015

LAR MFG., LLC - 12/09/2015


United States

Issuing Office:
Florida District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770


December 9, 2015
Delores M. Wallace
Director of Operations
6828 Commerce Avenue
Port Richey, FL 34668-6816 
DearMs. Wallace:
During an inspection of your firm located in Port Richey, Florida on August 31 – September 01, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that you manufacture ceramic dental brackets. 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 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, their manufacture, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
We received your written response on October 5, 2015, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations (FDA 483) issued to you. In your response, you failed to outline the specific steps for each observation that you will take to establish and follow written procedures and policies to comply with current FDA regulations, therefore; your response is inadequate.
The violations include, but are not limited to, the following: 
1.    Failure to validate, with a high degree of assurance and approve according to established procedures, a manufacturing process that cannot be fully verified by subsequent inspection and testing, to ensure the process will continue to meet specifications as required by 21 CFR 820.75(a).
For example, your firm has not validated the following processes for the manufacture of your ceramic orthodontic brackets: 
a)    The (b)(4) of your brackets using (b)(4) matter, Alumina Balls 95% and water.
b)    The bracket coating processes “(b)(4)” and “(b)(4)”. Both coating processes require (b)(4) of cleaning, heating, and mixing steps.
2.    Failure to establish procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). 
For example, your firm failed to establish procedures for the following requirements:
a)    Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b)    Investigating the cause of nonconformities relating to product, processes, and the quality system;
c)    Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d)    Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device;
e)    Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
f)    Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
g)    Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
3.    Failure to establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained which is required by 21 CFR 820.72(a).
For example, your firm has failed to establish procedures or a calibration frequency for the optical comparators, micrometer, and dial calipers used in the production and inspection of your ceramic orthodontic brackets. In addition, you did not have documentation to show this equipment is calibrated to ensure that the equipment is suitable for its intended purpose and is capable of producing valid results.
4.    Failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).
For example, you do not have a procedure for the acceptance of your incoming raw component, Lucalox Alumina Ceramic that is used in the manufacture of your ceramic orthodontic dental brackets. In addition, records documenting the acceptance of incoming components are not maintained. 
5.    Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184
For example, your firm does not maintain procedures defining the contents of device history records.   In addition, you do not record, check, or verify production steps and no documentation is available to confirm specifications are met.
6.    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).   Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:
a)    Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production;
b)    Monitoring and control of process parameters and component and device characteristics during production;
c)    Compliance with specified reference standards or codes;
d)   The approval of processes and process equipment; and
e)    Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
For example, there are no documented instructions, or manufacturing procedures to cover the manufacturing processes performed at your facility in the production of your ceramic orthodontic brackets.
7.    Failure to establish a procedure for quality audits, and to conduct and document quality audits, as required by 21 CFR 820.22. 
For example, there are no procedures for conducting quality audits and the most recent quality audit of your facility was performed on 01/12/2013.
Furthermore, our review of the inspectional evidence, including the information you provided to our investigators, revealed the following violation:
8.    Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e).
For example, in addition to the previously cited lack of procedures you have not established written quality system procedures and instructions for the following:
a)    Purchasing Controls [21 CFR 820.50]
b)    Nonconforming Product [21 CFR 820.90(a)]
c)    Management Reviews [21 CFR 820.20(c)]
d)    Document Controls [21 CFR 820.40]
You 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 Food and Drug Administration without further notice.  These actions include, but are not limited to: seizure, injunction, and/or civil money penalties.  Also, federal agencies are advised of the issuance of all 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 device have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken.  If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities.  If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
Your response should be sent to: Erica M. Katherine, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. 
Susan M Turcovski
Director, Florida District