| Public Health Service Food and Drug Administration |
| Central Region Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Telephone (973) 331-4900 |
Department of Health and Human Services
May 16, 2011
WARNING LETTER
VIA United Parcel Service
James Craigie
CEO
Church &Dwight Co., Inc.
469 North Harrison Street
Princeton, NJ 08543-5297
File No.: 11-NWJ-17
Dear Mr. Craigie:
During an inspection of your firm located in Princeton, New Jersey, on January 25, 2011, through February 17, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures condoms, powered toothbrushes, ovulation test kits, and pregnancy tests. 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.
Our inspection revealed that your devices, specifically the powered toothbrushes and condoms, 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. 360ij and 21 CFR Part 803 Medical Device Reporting (MDR) regulation.
We received responses from you dated March 8, 2011, and April 4, 2011, concerning our investigators' observations noted on the Form FDA-483, List of Inspectional Observations, that was issued to you.
We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to submit an MDR report within 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device marketed may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example, complaint reference number 4406914, involving a chipped tooth due to the Spinbursh, was not reported, and other injuries, including urinary tract infection (UTI) and contract dermatitis associated with your condoms, were not reported.
Your responses dated March 8, 2011 and April 4, 2011 appear adequate. You submitted an MDR for complaint reference number 4406194 and commented that you felt other MDRs could not be submitted because the specific complaint references were not identified on the FDA-483. As a systemic corrective action to address this observation, you planned to have the Medical Health Professional retrospectively review all urinary and contact dermatitis complaints during the 2009-2010 period. You also planned to report any complaints that are deemed reportable based on the 21 CFR Part 803 criteria embodied in the procedure, and you planned to complete this review and filing of any additional MDRs by March 31, 2011.
2. Failure to submit an MDR report no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device marketed has malfunctioned and this device or similar device that your firm markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, complaint 4472717 concerned a Spinbrush malfunction which led to an injury but was not reported within the reportable timeframe.
Your responses dated March 8, 2011 and April 4, 2011 are not adequate. You ultimately submitted an MDR for complaint 4472717: MDR 2280705-2011-00011, received on March 9, 2011. However, this event type was submitted as "Other" in the Event Description. You failed to consider this event to be a reportable serious injury or a reportable malfunction. This event, however, meets the definition of a reportable malfunction based on the fact that "likely to cause or contribute to a death or serious injury" was established by a previously submitted MDR (2280705-2009-00009). You stated that the Medical and Dental Health Professionals are in the process of conducting a comprehensive review of the likelihood that head slippage can cause death or serious injury and will have the review completed by April 15, 2011. The event type for MDR 2280705-201100011 should have been "Malfunction." The indicated device problem (i.e., brush head coming off) is considered a reportable malfunction.
3. Failure to submit a supplemental report to FDA within one month following receipt of information that was not provided when the initial report was submitted, as required by 21 CFR 803.56. For example, numerous examples of MDR records were observed that included only initial reports of incidents. No follow-up reports were made to report additional information that was not available at the time of the initial report that was later obtained, for example, evaluation of returned devices.
Your responses dated March 8, 2011 and April 4, 2011 are not adequate. You failed to submit the additional information by March 31, 2011, for the five reports for which your firm determined that follow-up information should be submitted.
4. Failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR Part 803.17. For example, you do not have a system that enables personnel to consistently distinguish between reportable and nonreportable events.
Your responses dated March 8, 2011 and April 4, 2011 are not adequate. Your MDR procedure, as written, will not allow your firm to meet the requirements of 21 CFR Part 803. The procedure fails to address documentation and filing requirements under Part 803.17(b). It is recommended that your firm separate the MDR reporting requirements from the reporting requirements of other regulatory authorities into a separate document or into a clearly marked section of an overall reporting document. The Consumer Complaint Handling Procedure includes a chart of how complaints are handled but does not describe how the information is evaluated or how a reportability decision is made. You provided a decision tree that provides a standardized review process/procedure for the determination of when an event meets the criteria for reporting as an MDR and added it to the SOP. The decision tree appears to clarify MDR decision making. However, your procedure still fails to address requirements of 21 CFR 803.17.
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.
Please notify this office in writing within fifteen 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 violations, or similar violations, 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 fifteen 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 Warning Letter. In addition, FDA has noted nonconformances with regard to section 501 (h) of the Act [21 U.S.C. 351 (h)), which are deficiencies of the following Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to adequately maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, numerous records of consumer complaints lacked complete documentation, had inappropriate closure codes, or incomplete investigations. Specifically, the Consumer Complaint Handling Procedure failed to include procedures for investigating individual complaints or for including the reason for not conducting an investigation. Several complaints were closed without any record of investigation and follow-up, including the following:
a. Complaint reference number 3886507 (MDR 2280705-2008-00005) involved a customer who cut her mouth three times from the use of the Spinbrush.
b. Complaint reference number 4606228 related to blisters in the genital area from condom use.
Your responses dated March 8, 2011, and April 4, 2011, are not adequate. We have recognized that you planned to revise the Call Center procedure to add additional closure codes for potential adverse events involving a medical device. In addition, you planned to carry out a quality review to check on the accuracy of selecting the proper code. You also opened a CAPA (CDPP11 03001) for in-depth study of the issues noted in the observation, to identify their root causes, and corrective and preventative actions and planned to complete the CAPA investigation and all identified corrective actions by July 31, 2011. However, you failed to provide evidence of implementation of your planned actions. In addition, your responses failed to address the incomplete documentation and investigation issues and a retrospective review of all complaints to determine accuracy of the assigned code.
2. Failure to adequately review, evaluate, and investigate complaints that represent· an event which must be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(d). For example, records of MDR reportable complaints failed to consistently include the relationship of the device to the event, whether the device was used for treatment or diagnosis, or whether the device failed to meet specifications. The following complaints failed to provide the required information as to whether the device was being used for treatment or diagnosis, or whether the device failed to meet specifications:
a. Complaint reference number 432021 (MDR 2280705-2009-00015) involved a Spinbrush that broke during use and chipped a tooth.
b. Complaint reference number 4100716 (MDR 2280705-2009-00006) related to the vibration of a brush that broke a front tooth.
c. Complaint reference number 4557096 (MDR 2280705-2010-00011) related to a Trojan condom that broke with the user developing discharge and burning during urination requiring medical attention and medication.
Your responses dated March 8, 2011 and April 4, 2011 are not adequate. We have recognized that you planned to implement a revised SOP that would include the aforementioned determinations by March 31, 2011. In addition, you planned to review all MDR reportable complaint records from 2009 to present to include the lacking determinations. However, your corrective action failed to include a systemic review of all complaints to determine if they also need to be addressed in the similar manner. Your revised GO-1322.6S procedure does not adequately address the aforementioned determination issues.
Your response should be sent to: U.S. Food & Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about the content of this letter please contact: Ms. Della Fave at 973-331-4910.
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, 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/
Diana Amador-Toro
District Director
New Jersey District
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