| 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: 3002900388
WARNING LETTER
CMS # 89144
March 25, 2010
Dr. Mark D. Noar, CEO and Chairman
3CPM, Inc.
7402 York Road #100
Towson, MD 21204-7532
Dear Dr. Noar:
During an inspection of your firm located in Towson, Maryland on September 28,2009, through November 6, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrogastrogram (EGG) 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) 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). For example procedures for Version (b)(4) EGG machine in (b)(4) or for the upgrade made to the Research Version device in (b)(4) which included a new Research Waterload Version and a Waterload Version.
2. Failure to establish and maintain adequate procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d). For example:
a. When requested, design output procedures and/or requirements for the upgrade from Version (b)(4) to Version (b)(4) done by (b)(4) and for the upgrade from Version (b)(4) Research device to Versions (b)(4) Research, Research Waterload device done (b)(4) could not be provided.
b. When requested, no evidence that design outputs were established and evaluated against design inputs document (b)(4) was provided.
c. There is no record of review and approval of device labeling, including review and approval of the labeling for the Research Version (b)(4) released (b)(4)
3. Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, as required by 21 CFR 820.30(e). For example, procedures were not established to ensure formal documented reviews of the design during the design planning process.
4. Failure to establish and maintain adequate procedures for verifying the device design and documenting the results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, as required by 21 CFR820.30(t). For example:
a. When requested, no documentation to confirm that the finished product conformed to specified requirement as stated in the (b)(4) was provided.
b. The design plan identifies what testing will be done to ensure general assembly requirements are met; however, when requested, the documentation to support testing that was performed on the following activities could not be located: (1) 'Test Type CF EGG Lead on CWE Head Stage," (2) "Test Type B on Respiration Connection" and (3) "Verify Cart - Tip Test."
5. Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
a. When requested no evidence to show that the validation test was performed as stated in Test Report (b)(4) was provided.
b. When requested, no evidence to support that the finished device was validated to include validation with the EGGSAS software was provided.
c. The Failure Modes Effect Analysis FMEA described in (b)(4) does not define the Average Likelihood of Occurrence (ALOO) for each value.
6. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. When requested, no procedure identifying how design changes made to the device are processed was provided.
b. When requested, no evidence that the changes made to the finished device or the research, research waterload, or waterload software versions were verified or validated to ensure that the changes are effective and did not adversely affect the finished product was provided.
c. When requested, no evidence to support the device software update from Research Version (b)(4) to Version (b)(4) was verified to meet design requirements as stated in the (b)(4) was provided.
d. When requested, no documentation to support that the changes to EGGSAS software were verified to demonstrate the functionality was provided. The EGGSAS version (b)(4) software is the software component for the EGG machine that is used in conjunction with the (b)(4) to provide a diagnosis of gastric motility disorders.
7. Failure to document all activities required under 21 CFR 820.100, Corrective and Preventive 21 CFR 820.100(b). For example:
a. Email correspondence between the dates of November 26, 2008 and December 1, 2008 discuss an install program for the 3CPM companion program, known as the Reader, and problems encountered during testing. The test methods are not identified, and the software used to test the program is not identified. The final email correspondence refers to a "problem" identified in the folder the program is run on. The program is not identified, nor is a resolution documented.
b. Email correspondence dated December 2, 2008 discuss the 3CPM companion programs known as the Reader and (b)(4) programs corrupting the EGGSAS software making the EGGSAS software "disappear" when the (b)(4) program was uninstalled. The emails discuss testing the Reader and (b)(4) programs to ensure the problem was fixed; however, no resolution is identified and/or documented.
c. Email correspondence between the dates of February 1 and February 3, 2009 discuss changes, upgrades, procedure/policy and software testing; however, the results of the testing or test methods are not documented.
d. Email correspondence on May 18 and 19, 2009 discuss the uninstall of EGGSAS software version (b)(4) on a Windows 98 notebook, which resulted in the uninstall of other programs on the customer's computer (not related to 3CPM). In an email from Mr. M. Ted Braid (CIO, 3CPM), he stated support is not offered for older versions of the EGGSAS software; however, an exception would be made in this instance. The email ended with the offer to purchase new equipment to support the older version of software or to purchase the newer version of software. The email was closed, and no date is provided. There is no evidence of an investigation.
8. Failure to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example, there is no defined method of identifying, documenting and evaluating nonconforming product and any investigation associated with the nonconforming product. Specifically, email correspondence between the dates of June 29 and July 6, 2009, indicate the need to correct a problem with the data entry field on the waterload software version; however, no further documentation is available addressing this issue.
9. Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, when requested no validation documentation to support the commercial off-the-shelf program (b)(4) used to capture complaints, returned merchandise and service requests was provided.
10. Failure to establish and maintain adequate acceptance procedures, where appropriate, to ensure that specified requirements for in-process product and finished device acceptance are met as required by 21 CFR 820.80(c) and (d). Finished device acceptance includes ensuring that each product, run, lot, or batch of finished devices meets acceptance criteria. For example, electrogastrograrn machine components and finished product acceptance and/or rejection criteria have not been established.
11. Failure to establish and maintain procedures for identifying product during all stages of receipt,production, distribution, and installation to prevent mixups, as required by 21 CFR 820.60. For example, there is no procedure or mechanism for identifying individual equipment components, software or finished device. Specifically, there are three versions of the EGGSAS software all identified as Version (b)(4): (1) a waterload version; (2) a research - waterload version; and (3) a research version.
12. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and to maintain distribution records which include or refer to the location of (1) the name and address of the initial consignee; (2) the identification and quantity of devices shipped; (3) the date shipped; and (4) any control number(s) used, as required by 21 CFR 820.160. For example, when requested, procedures for controlling and distributing finished devices and distribution records for products released into distribution for 2008 and 2009 were not provided.
13. Failure to establish and maintain device master records (DMR's), as required by 21 CFR 820.181. For example, when requested, no DMR for the EGGSAS software used in the three 3CPM Electrogastrogram versions: Research, Research Waterload, and Waterload was provided.
14. Failure to maintain adequate device master records that include, or refer to the location of, device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a). For example, when requested, the software specifications for the software update that occurred in (b)(4) or the software updates that occurred between (b)(4) could not be located.
15. Failure to establish and maintain procedures to ensure that device history records (DHR) 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 21 CFR Part 820, as required by 21 CFR 810.184. For example:
a. When requested, no DHR for the research, research-waterload or the waterload software Version (b)(4) tested and distributed to customers was provided.
b. There is no record of device labeling.
c. Changes to the software are not documented in the Design History File and are not tracked and/or verified. There is no documentation listing the number and/or type of changes that were made.
16. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40. The procedures should designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of 21 CFR Part 820. For example:
a. When requested, no procedures which address document control were provided.
b. The following unapproved documents are maintained in the Device History File, stored electronically, or are contract/(b)(4) agreements:
1. The 3CPM Company, Inc. (b)(4) with no review or approval signatures.
2. The Design Plan entitled (b)(4) undated with no review or approval signatures.
3. SOP number (b)(4) no approval signature.
4. Document number (b)(4) undated with no approval signature.
5. Document number (b)(4) dated Ma 14, 2003 with no approval signature.
6. Test Report (b)(4) written by the firm's independent consultant, but not approved by 3CPM management
7. (b)(4) but does not have a review or approval signature.
8. (b)(4) but does not have a review or approval signature.
9. (b)(4) but does not have a review or approval signature.
10. (b)(4) undated with no approval signature
11. (b)(4) undated with no approval signature
12. (b)(4) undated with no approval signature
13. (b)(4) but updated.
14. "CONTRACT SERVICES AGREEMENT" between 3CPM Company, Inc (b)(4) undated with no signatures.
17. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c). For example, when requested no documentation to support management reviews are conducted was provided.
18. Failure to establish procedures for quality audits and 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, as required by 21 CFR 820.22. For example, when requested, procedures for quality audits were not provided. Quality audits have not been conducted since 2003.
19. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, when requested, documentation that training was performed according to the design plan for the upgraded device from Version (b)(4) to Version (b)(4) could not be located. A troubleshooting chart was scheduled to be created; however, it could not be located; and training materials and a training class were to be provided/conducted on Customer Service and Sales/Marketing according to the Design Plan; however, the training materials or documentation that the training was conducted could not be located.
Our inspection also revealed that your electrogastrogram 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 C.F.R. Part 803 Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure or refusal 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 803 - Medical Device Reporting (MDR) regulation. For example, when requested procedures for MDR reportable events were not provided.
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 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 violations, or similar violations, 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.
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 assurance 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.
Please send your reply to the 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.
Sincerely,
/s/
Evelyn Bonnin
District Director
Baltimore District
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