VIA UNITED PARCEL SERVICE
Vice President, Quality Assurance
199 Grandview Road
Skillman, NJ 08558-1311
Dear Ms. Gorecki:
During an inspection of your firm located in Skillman, New Jersey, on December 12, 2011, through January 19, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following products: K-Y Liquibeads; K-Y Warming Liquid; K-Y Yours+ Mine; K-Y Jelly; K-Y Touch Massage 2 in 1; K-Y Sensual Silk Ultra Gel; Visine for Contacts; O.B. Tampons; Reach Floss; and Stayfree and Carefree Menstrual Napkins. 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 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.
We received written responses from your firm dated February 9, 2012; March 9, 2012; April 9, 2012; and May 9, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. 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 establish and maintain adequate complaint files and procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
A. Your firm received 227 K-Y Liquibeads Vaginal Moisturizer complaints from June 25, 2010 through December 12, 2011. Sixty-eight of these complaints were classified as medical complaints and were not adequately evaluated and investigated. These complaints included, but are not limited to: #30000287576, dated September 7, 2010; #30000313423, dated October 29, 2010; #30000322781, dated November 18, 2010; #30000324081, dated November 22, 2010 and #30000388589, dated March 30, 2011.
B. Your firm’s K-Y Liquibeads complaints associated with product subject codes “Does Not Dissolve” and “Uncharacteristic Consistency/Texture” were closed without any written justification. Written justification is required by Section 10.2 of your firm’s procedure, QSP-000619 “Requirements for Consumer Complaint Investigation By Quality Assurance, issued November 23, 2011.” Complaints included, but are not limited to: #30000309418, dated October 20, 2010; #30000456372, dated August 17, 2011; and #30000430385, dated June 27, 2011.
C. Your firm’s Quality Assurance did not adequately investigate all complaints specific to invalid lot numbers. For example, #30000435671, dated July 7, 2011, and #30000477372, dated October 5, 2011, were closed on July 27, 2011, and October 26, 2011, respectively. Both complaints were related to K-Y Liquibeads, Lot No. 0361W. Additionally, both complaints indicated that Lot No. 0361W was an invalid lot number and no investigation was required for invalid lot numbers. However, the lot number was valid and the complaints were never re-opened or adequately investigated.
D. Your firm closed 28 K-Y Liquibeads Vaginal Moisturizer complaints with a subject code of “Does Not Perform as Expected.” QSP-000324 “Quality Assurance Complaint Investigation and Closure for Products Within The Skincare and CHC Global Business Units and Consumer Pharma, issued December 12, 2011 ,”requires that Class II medical device complaints using this code are evaluated and investigated as medical complaints. The complaints were closed without further investigation or review by Quality Assurance. These complaints included, but are not limited to: #30000278862, dated August 22, 2010, and #30000467394, dated September 12, 2011.
The adequacy of your firm’s responses cannot be determined at this time. Your corrective actions cannot be adequately assessed until an investigation of each of the complaints is completed and provided to the FDA.
2. Failure to promptly review, evaluate, and adequately investigate complaints that represent an event which must be reported to FDA under part 803, by a designated individual, as required by 21 CFR 820.198(d). For example, your firm’s complaint investigation procedures, including QSP-000324, QSP-000619, and SOP-002003 “Quality Assurance Complaint Handling Within the Baby Beauty CHC and Consumer Pharma Global Business Units, issued March 10, 2011 ,”have not been implemented to ensure prompt review and adequate investigation of MDR reportable complaints. A total of 19 investigation records of MDR reportable complaints were reviewed during the inspection. Nine of the 19 records did not contain all of the required information, to include batch record reviews, review of product design, review for formula changes, and/or did not meet the (b)(4) day review timeframe, as required by your firm’s procedures.
This is a repeated QS regulation deficiency that was observed during the FDA inspection of your firm’s Skillman, New Jersey facility that ended on August 3, 2009.
The adequacy of the responses cannot be determined at this time. The corrective actions your firm proposed cannot be adequately assessed until the revised complaint investigation procedures and processes have been completed.
3. Failure to establish and maintain adequate procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example:
A. Your firm’s procedure, QSP-000381, “Design Control Process For Medical Devices, issued January 11, 2011” under section 188.8.131.52.1, states that design validation shall ensure that the device conforms to the defined user need(s) and intended uses(s) and shall include testing of the device under actual or simulated use conditions. The K-Y Liquibeads Vaginal Moisturizer product label states that the product is compatible with latex condoms. According to the Condom Compatibility Memo, dated April 13, 2011, your firm retrospectively reviewed condom compatibility by means of a silicone lubricant study using data from a previous study. The study did not include the K-Y Liquibeads Vaginal Moisturizer product and did not assess latex condom compatibility with fractionated coconut oil and fractionated coconut oil-lecithin, both of which are used in the formation of the shell of the K-Y Liquibeads ovule.
B. Your firm conducted a long-term stability study to determine the K-Y Liquibeads Vaginal Moisturizer product shelf life and storage requirements. The study lacked critical elements such as, but not limited to, review and approval prior to implementation, an established number of samples needed from each of the (b)(4) study lots, and a reference to the test method specifications for physical and chemical testing, as required by QSP6008 “Marketed Product Stability Program Management System for OTC Drug & Formulated Cosmetic and Devices, issued December 1, 2010.” Additionally, deviations from the study were d. For example, there was no justification for including an (b)(4) sample testing point and excluding preservative efficacy testing requirements. The results also did not include the actual temperatures of the stability chambers at the time of sample testing.
The adequacy of your firm’s responses cannot be determined at this time. The proposed corrective actions cannot be adequately assessed until implementation of your firm’s revised manufacturing procedures and processes have been completed. Additionally, the completed product stability study will need to be provided to the FDA for review.
4. Failure to document the results of the design review, including identification of the design, the. date, and the individuals performing the review, in the design history file (DHF), as required by 21 CFR 820.30(e). For example, your firm was unable to provide documentation of a design review meeting that was conducted on June 24, 2010.
This QS regulation violation was not placed on your firm’s FDA 483 but was discussed with management at the close of the inspection on January 19, 2012.
5. Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include the requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example:
A. Your firm’s procedures, WWSP027 and SOP-005393 “Management of CAPA (Corrective and Preventive Actions), issued August 30, 2011, and October 3, 2011,” do not include provisions for ensuring that a corrective and preventive action does not adversely affect the finished device.
B. Your firm’s CAPA effectiveness monitoring process is ineffective as it does not adequately verify or validate the action items within the corrective action plan. Examples of inadequate CAPA reports include: #1256, #1866, #2212, #2577, and #3395.
Your responses to Observation 5.a and 5.b of the FDA 483, appear to be adequate.
Our inspection also revealed that your Reach Floss and your O.B. Tampon products are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 -Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
1. Failure to report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
MDR 8041101-2010-00002 describes an event in which a person lost a tooth while using your firm’s dental floss. The loss of a tooth represents an injury that resulted in permanent impairment of a body function or permanent damage to a body structure. The report was received by FDA after 30 calendar days of your firm’s becoming aware date.
This is a repeated deficiency that was observed during the FDA inspection of your firm’s Skillman, New Jersey facility that ended on August 3, 2009.
Your firm’s responses to this observation appear to be adequate.
2. Failure to submit a supplemental report within 1 month of the day that your firm received information that was not provided because it was not known at the time the initial report was submitted as required by 21 CFR 803.56. For example:
For MDR 2214133-2009-00012, your firm received additional information from the patient’s medical record that confirmed the diagnosis of Toxic Shock Syndrome (TSS) after using an O.B Tampon. The supplement was submitted to FDA after one month from the day that your firm received information.
Your firm’s responses to this observation appear to be adequate.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.
Our inspection also revealed that the K-Y Liquibeads Vaginal Moisturizer product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C.§ 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For example, your firm made significant changes to the K-Y Liquibeads Vaginal Moisturizer product from the predicate device, such as the implementation of a gel capsule delivery system, the use of an applicator, and significant labeling changes. These changes require submission of a new 510(k).
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81 (b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet athttp://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
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: Food and Drug Administration, New Jersey District’s Compliance Branch, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. If you have any questions about the contents of this letter, please contact: Stephanie Durso, Compliance Officer at 1-973-331-4911.
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 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.
New Jersey District