Chan Ming Kei
- Bebe Toys Manufactory Ltd.
Xinteng Industrial Zone, Da Lin Shan
- Issuing Office:
- Center for Devices and Radiological Health
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10903 New Hampshire Avenue
Silver Spring, MD 20993
APR 6, 2017
VIA UNITED PARCEL SERVICE
Chan Ming Kei
Bebe Toys Manufactory Ltd.
Xinteng Industrial Zone, Da Lin Shan
Dear Mr. Kei:
During an inspection of your firm located in Dongguan, China, on September 19, 2016, through September 22, 2016, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures water filled teething 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 to affect the structure or 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 ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, manufacturing processes for the Baby King fluid filled teethers has not been validated, including but not limited to:
A. Your firm has not conducted validation studies for the sterilization process for the Baby King teethers. Your manufacturing process includes having the devices (b)(4) by a contract sterilizing facility; however, your firm has not determined the sterility assurance level (SAL), bioburden studies, load configurations, and minimum and maximum exposure time, and intensity to achieve the desired SAL without adversely affecting the quality of the teether devices.
B. Your firm has not performed validation studies for its (b)(4) machines used to manufacture its Baby King teethers, including but not limited to determining the minimum and maximum process parameters ((b)(4)) to ensure the product specifications are consistently met.
C. Your firm has not performed validation studies for its (b)(4), including but not limited to determining the specification and rationale for the quality of finished water used to fill Baby King teethers.
2. Failure to establish and maintain procedures to prevent contamination of product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e).
For example, the process to remove visible debris from rattles and teethers occurs by employees using their bare hands to wipe many rattles over several minutes with the same cloth dampened with water. There is no procedure for this process, or for sanitizing the table top where this process occurs prior to emptying the products directly onto the table, and no hand washing stations or hand sanitizing agents are available. This process occurs post (b)(4), just prior to final packaging.
3. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g).
For example, your firm’s (b)(4) system processes (b)(4) that is intended to be used to fill Baby King teether devices. There are multiple (b)(4) associated with the (b)(4), which can lead to contamination of the (b)(4), including but not limited to:
A. An approximate (b)(4) connected near the beginning of the (b)(4) and the uncapped loose end on the cement floor.
B. (b)(4), approximately (b)(4), connected to the (b)(4) were (b)(4) off the cement floor.
C. An approximately (b)(4) was observed to have one end connected toward the end of the (b)(4) and rest of the (b)(4) on the floor, including the (b)(4) end.
D. (b)(4) are between the various (b)(4) and the (b)(4); however, none of these (b)(4) have (b)(4) prevention devices in place to prevent unintended (b)(4).
4. 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).
For example, your firm failed to establish design control procedures, design inputs and outputs, acceptance criteria, and design validation for its fluid filled teether devices.
5. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100 (a).
For example, your firm did not follow its CAPA procedure titled “Non-conformance Control Procedure #BB-PM-09,” section 3.9, dated August 2012, for adequately documenting the effectiveness verification of the corrective and preventive measures. Additionally, two out of four CAPAs reviewed lacked adequate documentation of effectiveness verification and two lacked an adequate investigation:
A. NC #1501, dated November 27, 2015, resulted from an external audit and found a receiving record from a supplier that listed an incorrect expiry date. This NC report lacks documentation of effectiveness verification of the corrective action to assure that incoming material and component records are accurate.
B. NC #1502, dated November 27, 2015, resulted from an external audit and found that the office did not distribute an updated procedure manual to the warehouse. This NC report lacks an adequate initial investigation documentation of the scope of the issue, including determining if the other (b)(4) departments were issued the correct procedure manuals. It lacks documentation of effectiveness verification of the corrective action to assure that current procedure manuals are distributed throughout the facility.
6. Failure to establish and maintain records of acceptable suppliers, as required by 21 CFR 820.50(a)(3). For example, your firm lacks supplier qualification documentation for its contract laboratory, located (b)(4), which performs (b)(4) testing on samples of water contained in the finished teether devices.
7. Failure to maintain device master records (DMR's), as required by 21 CFR 820.181. For example, your firm does not maintain DMRs for its approximately 90 varieties of fluid filled teether devices.
8. Failure to maintain device history records (DHR's), as required by 21 CFR 184. For example, your firm does not maintain DHRs for batches/lots of the approximately 90 varieties of its fluid filled teether devices.
U.S. 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 deviations are reasonably related will not be approved until the violations 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, including 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 action (which must address systemic problems) 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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 512794 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Branch Chief, at firstname.lastname@example.org (e-mail) or 1-(240) 402-4020 (telephone).
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 Inspectional 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.
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health
Mr. Roy Pomerantz
Regent Baby Products Corp.
182-20 Liberty Avenus
Jamica, N.Y. 11412