Inspections, Compliance, Enforcement, and Criminal Investigations
Lifestyle GP Company, LLC 04-Sep-08
Department of Health and Human Services
Public Health Service
555 Winderley Place, Ste. 200
Telephone: (407) 475-4700
RETURN RECEIPT REQUESTED
September 4, 2008
Robert A. Smart
The Lifestyle GP Company, LLC
2530 Trailmate Drive
Sarasota, Florida 34243-4070
Dear Mr. Smart:
During an inspection of your firm located in Sarasota, Florida on 01/29/2008 through 02/01/2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures daily wear contact lens. 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 (C.F.R.), Part 820. We received a response from you on July 9, 2008, concerning our observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. These violations, include, but are not limited to, the following:
1. 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. Specifically, the Lifestyle Company, Inc. procedures acquired in the original sale in 2002, were never reviewed, updated, and/or purged to incorporate actual management approved procedures and forms, in that:
a) your firm's complaint procedures, OP 0525- Filling Out Device Complaint Reports, Rev: C, dated 1/31/01, was not incorporated by management. For example:
i) the procedure was not approved by management
ii) the complaint form FM 0026 referenced in the procedure was not adopted
iii) this procedure references procedure QAP 0141 Medical Device Reporting which has not been established and implemented by your firm
iv) the trending of complaints required by this procedure was not established and implemented
b) your firm's procedure OP 0545- GP Lab Equipment and Cleaning Procedure, Rev: B, dated 6/06/01, which indicates the lenses are cleaned [redacted] was not fully implemented since your firm cleans all contact lenses processed by hand.
c) your firm's procedures OP 0138- Base Curve Cutting, Rev: H, dated 12/7/98 and OP 0490- Power Changing refer to required maintaining document DHR 0010- Device History Record. Your firm does not maintain Device History Records as required by 21 CFR 820.
d) your firm failed to ensure that the Process and Process Control Procedures required by FDA regulations 21 CFR 820 were fully established and implemented.
2. Failure to adequately maintain procedures for implementing corrective and preventive action, and failure to document all activities and results under this section, as required by 21 CFR 820.100(b). Specifically, your firm failed to establish and implement Corrective and Preventive Action procedures as required by FDA regulations.
3. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). Specifically, your firm's complaint handling procedure OP 0525, Rev: C, dated 1/31/01 refers to documents and firm records established by the lens material manufacturer and not implemented by your firm. FDA regulations require timely review and investigation of complaints for which procedures have not been established and implemented by your firm.
4. Failure to fully validate and approve according to established procedures processes whose results cannot by fully verified by subsequent, inspection, as required by 21 CFR 820.75(a). Specifically, your firm's cleaning process using [redacted] polishing compound containing [redacted] was not validated to insure [redacted] was completely removed in your hand cleaning process.
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, as required by 21 CFR 820.184. Specifically, several procedures you provided which were identified as the firm's established procedures referred to documentation to be included in the DHR (DHR 0010), however, your firm does not maintain DHRs for your devices as required by FDA regulations.
6. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm failed to establish and implement written procedures to be utilized to insure the acceptance or rejection of contact lenses processed by your firm. The procedures reviewed were obsolete and failed to include documentation of management approval.
7. Failure to establish and maintain procedures for the acceptance of incoming product and/or components, as required by 21 CFR 820.80(b). Specifically, Incoming Acceptance Procedures have not been established and your firm failed to document incoming acceptance of components used in the manufacture of your RGP contact lenses.
8. Failure to establish procedures for quality audits and conduct such audits to assure the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, reference material obtained from your contact lens raw material suppliers, [redacted] and [redacted] via internet access or directly from company sources for [redacted] approval require finishing labs to maintain a quality audit system as required by FDA regulations 21 CFR 820.
9. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40.
10. Failure to establish procedures for identifying training needs and for ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, the procedures for identifying training needs were not established. Your firm also failed to document training of your employees responsible for quality and processing of your RGP lenses.
11. Failure to ensure that the calibration of the inspection, measuring, and test equipment is traceable to national or international standards, as required by 21 CFR 820.72(b)(1). Specifically, your firm failed to insure that the test lens set manufactured by [redacted] was manufactured and calibrated to NIST standards.
12. Failure to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). Specifically, your firm failed to insure that the hand held [redacted] and [redacted] micrometers used to measure lenses were calibrated to your calibration procedures.
We have reviewed your response dated July 9, 2008, and conclude that your responses to the above observations appear to be adequate. A follow up inspection will be required to assure that your corrections are adequate. We will contact you to arrange a mutually convenient establishment re-inspection.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to establish and maintain written MDR procedures as required by 21 CFR 803.17.
We have reviewed your response and concluded that it is inadequate because:
Firm's Response - "Management has developed and incorporated Medical Device Reporting Medical Vigilance System - Mandatory Problem Reporting QPR 0021." A review of your firm's Quality Procedures Document, (Ref QPR 0021 - Revision level 1.0) notes the following deficiencies in "PROCEDURE 2.0:"
1. 2.1 - your firm has combined the reporting obligations of the Vigilance and MDR systems making it difficult for employees to follow and make accurate MDR determinations.
2. 2.1.1 - your firm's definition of "May have caused or contributed to a death, serious injury, permanent impairment of body function, or serious deterioration of health. . ." is confusing; duplicates requirements; and may result in a failure to submit a required MDR report. For example, the procedure correctly lists "serious injury," but also includes "permanent impairment of body function" which is also a partial component of the MDR serious injury definition. Specifically, the definition of an MDR serious injury is ". . .an injury or-illness that: (1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure."
As written, your firm's procedures do not require the reporting of a life threatening event, permanent damage to a body structure, or an event that necessitates medical or surgical intervention, etc.
3. 2.2.1 - The procedure's reference to five day reporting is incomplete. Specifically, it does not include the requirement in 21 CFR 803.53 (b) which requires the submission of a five day report upon receipt of a request from FDA.
4. 2.6 - 2.7 "The initial Reporting" requirements does not meet the requirements of 21 CFR 803.52 (the MedWatch 3500A Reporting form/requirements).
5. Your firm's adverse event form [Ref. QF 0014, Revision Level: 1.0] does not include a complete listing of all MDR event types. For example, Death and Malfunction categories are not included as choices on the form. In addition, the form's introductory language repeats the confusing statements noted in 2.1.1 regarding serious injury and medical intervention.
6. Your firm's procedures should meet all the requirements in 21 CFR 803.17, i.e. "Medical Device manufacturers, importers, and user facilities are required to develop, maintain and implement written MDR procedures."
7. Other MDR deficiencies include:
•21 CFR 803.56 - Supplemental MDR Reports
•21 CFR 803.52 - Individual adverse event report requirements - (3500A)
•21 CFR 803.22 - When am I not require to submit an MDR report
[Note: 21 CFR 803.22(2)]
•21 CFR 803.18 - MDR event file requirements
•21 CFR 803.17(a) and 803.17(b) - Written MDR Procedures
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 FDA 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751 If you have any questions about the content of this letter please contact: Mr. Alejo 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 Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance 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.
Emma R. Singleton
Director, Florida District