- CMP Industries, Llc
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Food and Drug Administration|
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
September 9, 2015
WARNING LETTER NYK-2015-52
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Devon O. Howe
CMP Industries, LLC
413 North Pearl Street
Albany, NY 12207
Dear Mr. Howe:
During an inspection of your firm located in Albany, NY, on April 16, 2015 through May 29, 2015, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufacturer of the Impak Elastic Acrylic Resin Liquid and Impak Repair Acrylic Resin, indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base. 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 is intended to affect the structure or function of the body.
Quality System 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, its 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 received your firm’s responses dated June 5, 2015 and June 30, 2015, regarding our investigator’s observations included on the Form FDA-483 (FDA 483), List of Inspectional Observations, which was issued to you at the close of the inspection. We address these responses below, in relation to each of the violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified requirements are met as required by 21 CFR 820.30(a). Specifically, you did not implement design control procedures to control the design of your Impak Repair Acrylic Resin Liquid, part numbers (b)(4), in order to ensure that specified design requirements are met. For example, your firm has not conducted and/or documented design and development planning, design inputs, design outputs, design review, design verification, design validation, design transfer and/or design change activities. Further, no design history file has been created or maintained for your Impak Repair Acrylic Resin Liquid, part numbers (b)(4).
Your response to this observation is not adequate. In your response dated June 5, 2015 you state you did not realize the design history file for your Impak Repair Acrylic Resin Liquid was incomplete and that you will make a retrospective design history file within the next 30 days. You also state you will review any other devices that require a design history file. We acknowledge your follow-up response includes a Design Plan for the product, however, the design file remains incomplete for this product. Your responses do not include any review and/or revision of your design control procedures and/or relevant additional quality system procedures to prevent this violation from recurring.
2. Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your procedures for corrective and preventative actions (CAPA) do not ensure adequate investigation of the cause of nonconformities relating to product; identify the action(s) needed to correct and prevent recurrence of nonconforming product; and ensure via verification or validation that the corrective and preventive action is effective and does not adversely affect the finished device as evidenced by the following examples noted upon review of CAPA #69:
a) Your firm removed Impak Elastic Acrylic Resin Liquid lot number (b)(4) from the market due to your CAPA investigation identifying contamination in the raw material, Santicizer #(b)(4) lot number (b)(4), used in the manufacture of this finished device. However, your firm did not take any corrective action with respect to Impak Elastic Acrylic Resin Liquid lot number (b)(4) that was also manufactured with Santicizer #(b)(4) lot number (b)(4).
b) Your firm’s CAPA actions do not adequately investigate root cause of the nonconformity. Your firm concluded the root cause for contamination in the raw material, Santicizer (b)(4), as being a rust-like material present from decomposition of the drum holding Santicizer #(b)(4) lot number (b)(4), as confirmed by laboratory analysis. Your firm’s CAPA investigation did not review and evaluate additional lots of raw material Santicizer #(b)(4) in similar drums to ensure all affected drums/lots were identified. Your firm’s CAPA investigation did not determine whether the contamination identified in the raw material Santicizer #(b)(4) is also the same contamination identified in your bulk Impak Elastic Acrylic Resin Liquid CMP part #(b)(4). Your firm’s CAPA investigation failed to include review of Complaint 538 for Impak Elastic Acrylic Resin Liquid lot number (b)(4) that alleges “rust like specks in liquid” to determine if the complaint was related to the issue under investigation. Your firm concluded this complaint was a result of fiber like material contamination without any compositional or physical testing to support the complaint conclusion. Your firm’s CAPA procedure Corrective and Preventative Action, QA.PRO.15, Revision 6, requires that customer complaints are reviewed as part of CAPA actions.
c) Your firm’s CAPA actions were not adequate to prevent recurrence. Your correction includes requiring your supplier of Santicizer #(b)(4) to provide this raw material with each incoming shipment in new drums to prevent rust-like contamination concluded to be from decomposition of the drums upon re-use. However, your firm was observed to be re-using these emptied drums of Santicizer #(b)(4) to manufacture bulk Impak Elastic Acrylic Resin Liquid CMP part #(b)(4). Your CAPA actions do not ensure re-using these drums for manufacturing operations at your facility does not contribute to drum decomposition or contribute to contamination in your finished product.
d) Your firm’s CAPA actions did not verify or validate the actions in your CAPA are effective and do not affect the finished device. Your firm did not conduct compositional or physical analysis on incoming shipments of Santicizer #(b)(4) packaged in new drums to verify the corrective action eliminated the contamination of rust-like materials such as iron and/or other metals from leaching into the component and being processed into your firm’s finished devices. As per your firm’s CAPA #69 page 1, part b) Root Cause, “Rust cannot be seen by a visual inspection of inner drum when material is received.” Therefore, in the absence of some kind of laboratory analysis of the Santicizer #(b)(4), or of the finished devices, there is not verification that the corrective action is effective at identifying and removing the source of contamination.
We have reviewed your responses to this observation, dated June 5, 2015 and June 30, 2015, and have concluded they are not adequate. Your response does not indicate any actions will be taken with respect to Impak Elastic Acrylic Resin Liquid lot number (b)(4) that remains in distribution, manufactured with contaminated Santicizer #(b)(4) lot number (b)(4). While your response acknowledges the issues noted with your CAPA investigation, CAPA actions and CAPA verification activities and promises some corrections, including revision to your complaint procedures and some manufacturing procedures, no objective evidence was provided to support your statements. Although several issues are noted with your CAPA procedures, as evidenced by the examples presented with respect to CAPA #69, no review or revisions with respect to your CAPA procedures or to CAPA#69 were promised in your response.
Corrections and Removal Violations
Our inspection also revealed that your firm’s Impak Elastic Acrylic Resin Liquid is 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, as required under section 519 of the Act [21 U.S.C. § 360(i)], and Title 21, Code of Federal Regulations (CFR) Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
3. Failure to submit a written report of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. Specifically, on November 18, 2013, your firm contacted customers and requested they return Impak Elastic Acrylic Resin Liquid part numbers (b)(4), Lot number (b)(4). Letters were distributed on your firm’s letterhead that stated “we found that one of our processes could deliver a material that would pass our QC tests, but may introduce foreign material into the liquid” and “A customer service representative will be in contact with you to arrange the return of the product”. The issue was identified during production on November 15, 2013 and the removal was initiated because your investigation found the finished product may be contaminated with metal from one of the components, Santicizer (b)(4), Lot number (b)(4) CMP Part# (b)(4), used to produce Impak Elastic Acrylic Resin Liquid part numbers (b)(4), Lot number (b)(4).
Your firm failed to notify the FDA of the medical device correction or removal, and did not provide the information required by 21 CFR 806.10. Your firm’s actions have been reviewed by FDA and determined to meet the definition of a recall and should have been reported to the Agency.
We have reviewed your responses to this observation, dated June 5, 2015 and June 30, 2015, and have concluded they are not adequate. Your responses do not indicate you would report this medical device correction or removal, or a similar action, in the future. Your response does not include objective evidence to support corrections are proposed or have been made to correction and removal procedures to prevent this violation from recurring.
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of 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 devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your written response should be sent the Food and Drug Administration; Attention:
LCDR Catherine Beer
U. S. Food and Drug Administration
One Winners Circle, Suite 110
Albany, NY 12205
If you have any questions about the content of this letter please contact: LCDR Catherine Beer at (518) 453-2314 x1015.
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 the violations, and take prompt actions to correct the violations and bring the products into compliance.
Ronald M. Pace
New York District
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