| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human ServicesDecember 8, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 12
Kenneth M. Spett
President and Chief Executive Officer
GF Health Products, Inc.
2935 NE Parkway
Atlanta, Georgia 30360
Dear Mr. Spett:
During an inspection of your firm, GF Health Products, Inc./d.b.a. Basic American Metal Products, located at 336 Trowbridge Drive, Fond du Lac, Wisconsin, on August 29, 2011, through September 23, 2011, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures electrical-powered and manual beds for long-term care and homecare. 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 (CFR), Part 820. We received responses from you dated October 14 and November 4, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (Form 483), issued to Kurt J. Hellman, Senior Vice President Manufacturing Operations. We address your responses below. Violations include, but are not limited to, the following:
1. Failure to establish adequate procedures for corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). Specifically:
a. There was no investigation or root cause analysis performed for CAPAs 1017, 1018 and 1019, which is required by your Site Operating Procedure (SOP) 820.100.10 Corrective and Preventative Action (CAPA), Effective Date 11/23/2009, Rev. B, section 7.3.
b. CAPAs 1016 and 1009 do not include a review of the original data source in the effectiveness check, which is required by your Corporate Operating Procedure (COP) 08-300 CAPA - Corrective and Preventive Action, Effective Date 12/15/2006, Rev. B, section 5.6.
c. An independent audit was not performed for CAPAs 1015, 1010 and 1011. SOP 820.100.10, section 7.4.3, requires follow-up to be performed by an independent audit to prevent any bias. However, for these CAPAs, the “Root Cause Research and Corrective Action Development” and the “Follow-up” tasks were assigned to and performed by the same employee.
2. Failure to include required information in records of complaint investigation as set forth in 21 CFR 820.198(e). Specifically, the dates and/or results of investigations were not documented for complaints 16669, 10468, 15149 and 9759. SOP 820.198.10 Complaint Files, Effective Date 12/05/2008, Rev. B section 6.3.3 states “Complaint investigation records should include the dates and results of the investigation.”
3. Failure to establish procedures for finished device acceptance, which is required by 21 CFR 820.80(d). Specifically, no procedure has been established for finished device acceptance activities to ensure that each production run, lot, or batch of finished devices meets acceptance criteria.
4. Failure to establish adequate procedures for the acceptance and control of in-process product as required by 21 CFR 820.80(c). Specifically:
a. The GF Health Products Assembly Department Control Plan for Part Number (b)(4), Revision Level B, states to perform (b)(4) inspection of the following characteristics: (b)(4).
i. Only one inspection was documented on the control plan record for serial numbers (b)(4) manufactured on 12/30/2009. (b)(4) inspections should have been performed.
ii. Only one inspection was documented on the control plan record for serial numbers (b)(4) manufactured on 12/14/2009. (b)(4) inspections should have been performed.
b. The GF Health Products Assembly Department Control Plan for Part Number (b)(4), Revision Level C, states to perform a (b)(4) inspection of the following characteristics: (b)(4).
i. Only two inspections were documented on the control plan records for serial numbers (b)(4) manufactured on 12/16/2009. (b)(4) inspections should have been performed.
ii. Only one inspection was documented on the control plan for serial numbers (b)(4) manufactured on 12/21/2009. (b)(4) inspections should have been performed.
5. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, which is required by 21 CFR 820.198(a). Specifically, COP 08-500 Complaint Handling, Effective Date 6/24/2010, Revision G, section 3.1.6, states that Quality is, “Responsible for investigating, documenting and closing complaints within 30 day target completion/closure.” The following complaints were not adequately investigated, documented, and closed within the 30 day timeframe; and there was no documented reason for the complaint remaining open past the 30 days.
a) Complaint #9734 was received 11/15/2010, the DC Evaluation task was closed 1/31/2011 and the complaint was closed 4/18/2011.
b) Complaint #16909 was received 6/21/2011 and was in “open” status when reviewed during the inspection (8/31/2011) without a documented investigation.
c) Complaint #16669 was received 06/13/2011 and was in “open” status when reviewed during the inspection (8/31/2011) without a documented investigation.
6. Failure to base sampling plans on a valid statistical rationale as required by 21 CFR 820.250(b). Specifically, there is no valid statistical rationale for the following sampling plans:
a. The GF Health Product Assembly Department Control Plans used during in-process acceptance activities require product to be inspected for identified characteristics at a defined frequency. For example, the Control Plan for Part (b)(4), Revision Level B, instructs to inspect for (b)(4) with no statistical rationale for that inspection frequency.
b. SOP 820.80.10 Receiving Inspection, Effective Date 08/09/2005, Rev. C, section 6.2, states (b)(4). There is no statistical rationale for the quantity of products to be inspected.
c. Engineering Change Request FDL-10-077 was initiated for (b)(4). Validation testing of the change was performed on (b)(4) before the design change was implemented. There was no valid statistical rationale for testing (b)(4) during validation.
7. Failure to establish 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). This is required by 21 CFR 820.184. Specifically, procedures to ensure that device history records are maintained did not exist upon initiation of the inspection.
8. Failure to establish and maintain adequate document control procedures as required by 21 CFR 820.40. Specifically, SOP 820.40.10 Document Controls, Effective Date 10/01/2008, Rev. C, section 6.4, states (b)(4). Section 6.7 states (b)(4). The following documents do not comply with SOP 820.40.10, as noted below:
a. There was no evidence of approval of changes to the GF Health Products Assembly Department Control Plans for Part Number (b)(4). In addition, there is no record of the changes maintained in the (b)(4).
b. The Bed Line Assembly Inspection and Serial Number Log is not a controlled document, and there is no evidence of review or approval of the document.
We reviewed the Form 483 responses dated October 14 and November 4, 2011, concerning the above-noted violations of the Quality System regulation, 21 CFR 820. The corrective actions described appear to be adequate; however, a follow-up inspection will be necessary to fully assess the implementation and effectiveness of your corrections.
Our inspection also revealed that your Lumex Patriot Homecare Beds 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 section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Reports of Corrections and Removals regulation. Significant violations include, but are not limited to, the following:
1. Failure to report in writing to FDA a correction or removal conducted to reduce a risk to health posed by a device as required by 21 CFR 806.10(a)(1). Specifically, complaint number 5596 was received on June 29, 2010, from a medical equipment distributor alleging that a Lumex Patriot Homecare Bed end failure caused patient injury. On July 7, 2010, CAPA 1016 was opened by the firm due to complaints, including complaint 5596, of bed end failures for the Lumex Patriot Homecare Bed. As corrective action to CAPA 1016, your firm performed a field correction by replacing all bed ends located at the medical equipment distributor who reported complaint number 5596. In addition, customers who filed similar complaints for the Lumex Patriot Homecare Bed end were sent replacement product and were verbally instructed to dispose of their existing product. This field correction was not reported to FDA.
2. Failure to keep a complete record of a correction or removal that was not required to be reported to FDA under 21 CFR 806.10. Per 21 CFR 806.20(b)(4), a justification for not reporting the correction or removal action to FDA (including conclusions, follow-ups, and reviews by a designated person) must be included in the record. Specifically, on 1/5/2010, CAPA 1015 was opened to address complaints from the field involving the failure of control boxes on the Zenith III, Matrix II and Novus Longterm Care Beds. An investigation of the problem determined that the control boxes had the potential to stop functioning. Your firm performed a field correction between March - November 2010, replacing a total of (b)(4) control boxes that had been distributed to customers. Documentation to support the justification for not reporting the action to FDA was not completed at the time of the correction. This documentation was provided during the inspection on 8/31/2011.
We reviewed the Form 483 responses dated October 14 and November 4, 2011, concerning the above-noted violations of 21 CFR Part 806 – Reports of Corrections and Removals. Your response to the violation noted in #2 above, regarding the failure to keep a complete record of a correction or removal that was not required to be reported to FDA, appears to be adequate. However, a follow-up inspection will be necessary to fully assess the implementation and effectiveness of your corrections.
Your response to the violation noted in #1 above regarding the failure to report a correction or removal conducted to reduce a risk to health posed by a device is not adequate. Our concerns include:
o We disagree with your conclusion that the field correction on Lumex Patriot bed ends was not reportable under 21 CFR 806. The field correction was done to reduce a risk to health caused by (b)(4) which could lead to failure. When failure occurs, the bed can “descend rapidly causing non-typical patient movement.” Your own “Health Hazard Assessment Tool,” QF 08-501-01, Revision B, states that injury is “Unlikely but Possible”; and complaint 5596 reported minor injuries, including a bump on the head and bruised elbow to the patient and bruises to the patient’s wife who was knocked to the floor when the bed collapsed.
o We also disagree with the strategy of your correction. In particular, your firm: (1) replaced all bed ends from the customer associated with complaint 5596, (2) replaced bed ends associated with complaints from other distributors/customers, and (3) reworked stock from suspect lots. However, you did not identify and correct all bed ends containing (b)(4).
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 deviations 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 devices have been corrected.
Please notify this office in writing, within 15 working days from the date you receive this letter, with an update on the status of the specific steps you have taken to correct the violations cited in this Warning Letter. Include an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Please provide documentation of the corrective actions 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612) 758-7133.
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 close-out 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 to bring your products into compliance.
Sincerely,
/s/
Elizabeth A. Waltrip
Acting Director
Minneapolis District
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