Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
May 18, 2012
Mr. Mohamad Mansoori
Advanced OrthoPro, Inc.
1820 N. Illinois Street
Indianapolis, IN 46202
Dear Mr. Mansoori:
During an inspection of your firm located in Indianapolis, IN on April 16, 2012, through April 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AOI Cranial Remolding Helmets. 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 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:
1. Failure to establish and maintain procedures for developing, conducting, controlling, and monitoring production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm does not have a documented process control procedure that describes any process controls necessary to ensure conformance to specifications. Although you provided the investigator with a one page document entitled "Helmet Mold Modification Instructions", which was developed during the course of the inspection, this document does not meet the requirements listed in 21 CFR 820.70(a)(1-5) in that it does not include: 1) instructions, procedures and methods that define and control the manner of production, 2) the monitoring and control of process parameters, and component and device characteristics during production, 3) compliance with specified reference standards or codes, 4) the approval of processes and process equipment, and 5) criteria for workmanship that is expressed in documented standards or by means of identified and approved representative samples.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically, you have not established: 1) specifications for the raw materials used to manufacture the AOI Cranial Remolding Helmet; and 2) criteria for the selection and evaluation of suppliers.
3. Failure to establish and maintain adequate procedures for acceptance of incoming product, which shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). The FDA investigator was told that there is not an established procedure for the acceptance of the incoming raw materials used to manufacturer the AOI Cranial Remolding Helmets.
4. Failure to establish and maintain adequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198( a). Your "Complaint Procedure" does to ensure: 1) complaints are processed in a uniform and timely manner; 2) Oral complaints are documented upon receipt; and 3) complaints are evaluated to determine whether the they are reportable under 21 CFR 803.
5. Failure to adequately maintain Device Master Record (DMR) for each type of device which include or refer to the location of all the information as required by 21 CFR 820.181(a). During the course of the inspection, our investigator was told that your firm did not have a DMR for the AOI Cranial Remolding Helmet and the firm was not aware of what documentation the DMR would contain.
6. Failure to establish and maintain procedures to ensure that the 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 and the requirements of this part, as required by 21 CFR 820.184. Specifically, your firm has not defined, documented, and implemented procedures to define how DHRs are to be created and maintained.
7. Failure to establish adequate procedures for identifying training needs, ensuring that all personnel are trained to adequately perform their assigned responsibilities, and documenting training performed as required by 21 CFR 820.25(b ). Your quality manual, section 6.2.2(e) states that your firm will maintain appropriate records of education, training, skills and experience; however, these records have not been maintained.
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 the address above, attention: Steven Barber; Director, Compliance Branch. If you have any questions about the contents of this letter, please contact Mr. Barber at 313-393-8110 or at firstname.lastname@example.org. 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 lnspectional 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.
Glenn T. Bass
Detroit District Office