| Public Health Service Food and Drug Administration |
| Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5454 Fax: (410) 779-5703 |
Department of Health and Human ServicesFEI: 3005021665
WARNING LETTER
CMS# 128630
November 16, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Joseph F. Terpenning, C.O.
Eastern Cranial Affiliates, LLC.
1600 Wilson Blvd
Suite 200
Arlington, VA 22209
Dear Mr. Terpenning:
During an inspection of your firm located in Arlington, Virginia on June 15, 16, and 18, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures KidCap Cranial Molding Orthosis devices. 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 your response dated July 15, 2010 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for changes to a procedure as required by 21 C.F.R. § 820.70(b). Specifically, your firm changed its manufacturing procedure for the KidCap Cranial Molding Orthosis device in (b)(4) however, your firm did not have an updated fabrication protocol available for review that contained instructions that define and control the manner of the production. In addition, your firm had no documents available for review indicating that the production change had been verified or validated in accordance with 21 C.F.R. § 820.75, before implementation and that the production change was approved in accordance with 21 C.F.R. § 820.40.
2. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high decree of assurance and approved according to established procedures. The validation activities and results shall be documented as required by 21 C.F.R. § 820.75(a). For example,
a. You have not conducted validation studies on the production change implemented by your firm to measure patient's heads for the KidCap Cranial Molding Orthosis device. Specifically, your firm has not established operational qualifications or performance qualifications for the (b)(4) digital scanner currently used to measure patient's heads. In addition, your firm had no documentation available for review to demonstrate that the software used to operate the (b)(4) digital scanner had been installed in accordance with the manufacturer's instructions.
b. You have not conducted validation studies on the production change implemented to obtain a mold of the patient's head for the KidCap Cranial Molding Orthosis device. Specifically, your firm has not conducted validation studies to determine if the (b)(4) molds currently used are as accurate as the plaster impressions previously used. In addition, your firm has not conducted validation studies to determine if the (b)(4) molds are suitable for use as a template for this device.
3. Failure to establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured as required by 21 C.F.R. § 820.20(d). The quality plan in use at your facility addresses patient care rather than the KidCap Cranial Molding Orthosis device.
4. Failure to conduct reviews of your manufacturing procedures as required by your "Performance Management and Improvement" and "Manufacturing Audit" procedures respectively, in accordance with 21 C.F.R. § 820.20(c). Your firm's "Quality Assessment and Improvement Plan (rev 8/15/02)" assigned the responsibility of quality assessment and improvement to the chief executive officer (CEO), however, your firm failed to document that a management representative had been appointed to ensure that quality system requirements are effectively established and effectively maintained as required by 21 C.F.R. § 820.20(b).
5. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820, in accordance with 21 CFR § 820.40. For example, documents are to be reviewed and approved prior to issuance. The approval, including the date and signature of the individual approving the document, shall be documented as required under 21 C.F.R. § 820.40(a). However, your firm's procedures for performance management, manufacturing audits, design control, production control, adverse event reporting, and corrective and preventive actions (CAPA) did not include the date of approval or the signature of the approving individual. Furthermore, your firm has failed to maintain records of changes to these documents, as required by 21 C.F.R. § 820.40(b). This was a repeat violation from a previous inspection.
For example, your firm changed its manufacturing procedure for the KidCap Cranial Molding Orthosis device in (b)(4) however, your firm did not maintain records describing the manufacturing change as required by 21 C.F.R. § 820.40(b). This includes a description of the change, identification of the affected documents, the signature of the approving individual, the approval date, and when the change became effective.
6. Failure to establish and maintain procedures to control the design of the KidCap Cranial Molding Orthosis device in order to ensure that the specified design requirements are met as required by 21 C.F.R. § 820.30(a). Specifically, your design control procedure titled "Design Control (no rev; no date)" does not contain procedures for design and development planning, design input, design output, design review, design verification, design validation and design transfer. In addition, your design change procedure titled "Device Change Protocols for the Cranial Orthosis (no rev; no date)" does not state how non-customizing design changes will be handled. This was a repeat violation from a previous inspection.
7. Failure to ensure that a Device Master Record (DMR) was prepared and approved for the KidCap Cranial Molding Orthosis device manufactured by your firm, as required by 21 C.F.R. § 820.181. Specifically, your firm has not established a DMR for the KidCap Cranial Molding Orthosis device.
8. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product or services conform to specified requirements as required by 21 C.F.R. § 820.50. Specifically, your firm has not established acceptance criteria for (b)(4) plastic used in the production of the KidCap Cranial Molding Orthosis device. The receipt documentation from (b)(4) failed to include an acceptance signature and comparison to reference specifications. In addition, no acceptance criteria have been established for the receipt of the (b)(4) molds used as a template to manufacture the KidCap Cranial Molding Orthosis device.
9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and to document such training as required by 21 C.F.R. § 820.2S(b). The training records lacked documentation that employees involved in the manufacturing of the KidCap Cranial Molding Orthosis device received instruction concerning device defects that may occur from the improper performance of their specific jobs.
We have reviewed your July 15, 2010 response and have concluded that it is inadequate because your response did not provide specific information about when corrective actions would be implemented.
Our inspection also revealed that your KidCap Cranial Molding Orthosis devices are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), in that your firm represented on your website, as well as your "KidCap" brochure, that the KidCap is "an FDA approved helmet," and that the "KidCap has been approved by FDA pursuant to 510(k) 020448." These statements are misleading in accordance with 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).
We have reviewed your response and have concluded that it is inadequate because your response did not address when this information would be removed from your brochure.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 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 violation(s), or similar violation(s), 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: U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely,
/S/
Evelyn Bonnin
District Director
Baltimore District Office
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