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Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-20
March 9, 2011
Mr. Alan R. Finnieston
President
BioSculptor Corporation
2480 W 82nd Street, Suite 8
Hialeah, FL 33016-2726
Dear Mr. Finnieston:
During an inspection of your firm located in Hialeah, Florida on November 29, 2010 through November 30, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the CAMLab Cranial Orthosis Helmet and various other Class I devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
This inspection revealed that the CAMLab Cranial Orthosis Helmet, including the FastScan Laser, 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 is 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 a response from Mr. Mark Mazloff dated December 16, 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, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example:
There were no corrective and preventive action procedures provided or available upon request.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to create and implement a corrective and preventive action procedure.
2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example,
There were no design control procedures provided or available upon request.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to create and implement more thorough design control procedures.
3. Failure to establish and maintain design validation procedures to ensure that the device conforms to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of design validation, including the identification of the design, methods, the date, and the individuals performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). For example:
The labeling of the Cranial Orthosis Helmet document titled, “Practioner & Caregiver Labeling Information”, states, “Special Controls: Warnings and Contraindications (for Practitioners) and Practitioners Instructions and Strategies for Improving Fit”, however the risk analysis was not documented to reveal the severity and probability of these failures.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to document the risk analysis for the kinderBAND design and outline the probabilities and severity levels of known issues.
4. Failure to maintain adequate complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
Complaint forms have been developed, however no complaint procedures were provided or available upon request, that addressed the requirements such as receiving, reviewing and evaluating complaints.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to create and implement complaint procedures that require the investigation of complaints by a designated unit and correctly document corrective actions in response to all complaints.
5. Failure to establish and maintain procedures for changes to a specification, method, process, and procedure as required by 21 CFR 820.70(b). For example:
The change control forms have been developed, however there were no procedures available for instructing personnel on the proper use and completion of the change control forms.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to establish, train, and implement procedures instructing personnel on proper use and completion of change control forms specifically for design and process.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
The purchasing control procedures that discuss the evaluation and acceptance requirements to be met by suppliers, contractors, and consultants, were not provided or available upon request.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to establish and implement procedures governing approval and evaluation monitoring of critical vendors. In addition, your firm plans to include the requirement that changes in specifications of device components must be approved and documented prior to the change becoming effective.
7. Failure to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example:
The internal quality audit procedures were not available upon request.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to establish procedures for conducting internal quality audits of your Quality System.
8. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part (21 CFR 820), as required by 21 CFR 820.20(c). For example:
The management review procedures were not available and there was no documentation of management reviews being conducted.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. The response only states your firm plans to establish procedures to insure management with executive responsibility has reviewed and evaluated the Quality System at periodic intervals as required.
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 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant violations include, but are not limited to, the following:
9. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, your firm has no written MDR procedures and does not have an internal system to provide for effective identification, communication, and evaluation of events that may be subject to MDR requirements. Furthermore, your firm does not have a standardized review process or procedures for determining when an event meets the criteria for reporting required by the MDR regulation.
We reviewed your response and conclude that it is not adequate because your response does not provide supporting documentation or discuss the systemic corrective actions you plan to implement. Your response only states your firm plans to create and implement Medical Device Reporting 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 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 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 (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.
Your response should be sent to: Winston R. Alejo, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. Refer to the Warning Letter (FLA-11-20) when replying. 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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management 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.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
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