Inspections, Compliance, Enforcement, and Criminal Investigations
TOADS LLC 2/22/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
February 22, 2013
VIA UNITED PARCEL SERVICE
David B. Baughman, President
1226 Rowan Street
Louisville, Kentucky 40203-1446
Dear Mr. Baughman:
During an inspection of your firm located in Louisville, Kentucky on October 30, 2012 through November 28, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Orthodontic Temporary Anatomical Anchor Device Systems. 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
- You have not adequately established and maintained procedures for design change control as required by 21 CFR 820.30(i). Specifically, your firm has made approximately (b)(4) design changes without documenting validation activities. For example:
- On 2/9/11 your firm developed specifications for a Orthodontic Temporary Anatomical Anchor Device (TAAD) Mini Anchor that appears to be a different design from your cleared 510K (K063149).
- Change record number 08010101 dated 01/08/08 documents changing the (b)(4) of (b)(4) the Infra-Zygomatic Process Anchor by (b)(4) feature for consistency with the Palatal Approach Anchor.
- Change record number 06070080 dated 08/21/07 documents changing the (b)(4) from a (b)(4) to a (b)(4).
- Change record 06070081 dated 08/17/07 documents (b)(4) from the Infra-Zygomatic Process Anchor.
- Change record 06070075 dated 05/05/07 documents (b)(4) of the Mesial Anchor to match the (b)(4) of the Infra-Zygomatic Anchor.
- Change record 06070077 dated 05/05/07 documents (b)(4) of the Incisal Anchor to match the (b)(4) of the Infra-Zygomatic Anchor.
- Change record 06070076 dated 05/03/07 documents (b)(4) of the Palatal Anchor (b)(4) to match of the Infra-Zygomatic Anchor.
- You have not adequately established requirements that must be met by contractors as required by 21 CFR 820.50(a). Specifically, your firm has not ensured that your contract manufacturer has validated the process using the (b)(4) to manufacture the Orthodontic Temporary Anatomical Anchor Device Systems (TAADS) distributed by your firm.
- According to your Supplier Agreement, dated 10/7/09, it is your contract manufacture's responsibility to complete "production process validations where verification [is] not possible.” Your device history records for product numbers 270102, 270104, 270106, and 270108 document the final inspection and sometimes in-process inspections of each lot. During these inspections verification of all characteristics for each TAAD is only completed on the first device of each lot.
- Design input requirements were not adequately documented as required by 21 CFR 820.30(c). Specifically, your design inputs are not written in clear, specific, measurable terms. For example the design input requirements for your firm's Orthodontic TAADS (K063149) product numbers 270102, 270104, 270106, and 207108 include:
In addition, your design inputs have not been signed and dated to document approval by the most responsible official/ management representative of your firm.
- You have not adequately established procedures for corrective and preventive action as required by 21 CFR 820.100(a). Specifically, your firm has not documented end user/ customer feedback per your Customer Feedback Procedure, QP10.1, Rev. A dated 12/13/08 and your firm is not documenting the examination of returned product as required by your firm's "Corrective and Preventative Action" procedure, QP10, Rev. B dated 9/25/2009. For example,
- Your firm's President stated after talking to industry (orthodontists) at different conventions, your firm developed specifications (approved on 3/22/10) and began distributing an accessory used to temporarily implant your Orthodontic TAADS. However, there is no documentation of any received end user/ customer feedback.
- Your firm’s Director of Sales and Marketing has received customer feedback via e-mail on 3/26/12. This customer feedback was not transferred to your customer feedback form and reviewed as a source to your CAPA system.
- Your firm's invoice number 00005384 dated 9/29/11 documents the return of three (3) Infra-zygomatic Process Anchors, product number 270104, two (2) Palatal Approach Anchors product no. 270104, seven (7) Mesial Anchors, product no. 270106, and three (3) Incisal Anchors, product no. 270108. You have not documented the examination of this return.
- Your firm's invoice number 00005376 dated 08/04/11 documents the return of two (2) Infrazygomatic/ Zygomatic Anchors product number 270102. You have not documented the examination of this return.
- You have not adequately established procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a). Specifically, your supplier agreement states you are responsible for the "review of nonconforming product, acceptance approval for concessions, and associated corrective action requests." However, your firm has not documented non-conformances at the manufacturing nor have these non-conformances been analyzed to determine if a corrective action or preventative action was necessary as required by your firm's "Control of Nonconforming Product" procedure, QP9, Rev A. dated 4/25/2007. For example,
- Device History Record for product number 270108, Incisal Anchors lot number 001743 dated 10/6/10, documents 12 rejected devices.
- Device History Record for product number 270106 lot number 2042 dated 1/25/12, documents 7 rejected devices.
- You have not adequately established procedures for control and distribution of finished devices as required by 21 CFR 820.160(a). Specifically, your firm has not maintained distribution records per your "Handling Storage Installation and Distribution" procedure, QP12, Rev. C dated 12/16/08. For example:
- The DHR for part number 270108 lot number 1743 dated 10/6/10 documents the acceptance of 195 devices. According to your firm's Device Distribution Summary dated 11/6/12 approximately 173 devices were shipped to customers. There are 22 unaccounted for devices.
- The DHR for part number 270104 lot number 1725 dated 2/21/11 documents the acceptance of 197 devices. According to your firm's Device Distribution Summary dated 11/6/12 approximately 155 devices were shipped to customers and two (2) remain in your firm's inventory. There are 40 unaccounted for devices.
- The DHR for part number 270106 lot number 2042 dated 1/25/12 documents the acceptance of 192 devices. According to your firm's Device Distribution Summary dated 11/6/12 approximately 120 devices were shipped to customers and 38 of these devices remain in your firm's inventory. There are 34 unaccounted for devices.
- You have not adequately established procedures for training and identifying training needs as required by 21 CFR 820.25(b). Specifically, your firm established training procedures under QP2, "Management Responsibility" Rev. D, dated 12/11/08 according to this procedure on page 2 under section 5.1.2 Personnel "All TOADS' employees receive training on the relevance of the Quality Policy to their responsibility as employees, regulatory compliance obligations, and their responsibilities required of their respective job descriptions." This has not been completed. For example:
- Per your firm's job description key responsibilities for the Director of Sales and Marketing, is to "serve as the point of contact for customer feedback including customer complaints, requests for improvement, and opportunities for new product development". As of 10/30/12 your firm has not trained your Director of Sales and Marketing on procedures necessary to complete their job function as it pertains to Customer Feedback, Complaint Handling, and Corrective and Preventative Action. In addition, the Director of Sales and Marketing has received customer feedback which has not been documented according to your procedure, neither have they received training on your Complaint Handling procedure in order to determine if received customer feedback is a complaint that requires an investigation.
As noted above, our inspection also revealed that on 2/9/11 your firm developed specifications for an Orthodontic Temporary Anatomical Anchor Device System (TAADS) Mini Anchor that appears to be a different design from your cleared 510(k) (K063149). The inspection also revealed that your firm distributed at least two shipments of those devices.
Your firm’s Orthodontic Temporary Anatomical Anchor Device System (TAADS) Mini Anchor is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Orthodontic TAADS is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).
Specifically, your firm modified the Orthodontic TAADS, cleared under K063149, (b)(4) impacting the recommended placement location and recommended applied load. For a device requiring premarket approval, the notification required by section 510(k) of the act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information your firm needs to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information your firm submits and decide whether your product may be legally marketed.
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 (including any systemic corrective actions) 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 firm’s response should be sent to: Stephen J. Rabe, Compliance Officer at the address listed in the letterhead. You can contact Mr. Rabe by telephone at: 513-679-2700 extension 2163 or via email at: firstname.lastname@example.org. Refer to Warning Letter CIN-13-391494-14 when replying.
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.
Paul J. Teitell