Inspections, Compliance, Enforcement, and Criminal Investigations
He Gao Plastic Factory 3/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 20 2012
VIA UNITED PARCEL SERVICE
Mr. Kai-Ping Chan
He Gao Plastic Factory
Block A, 2/F, Gee Luen Factory Building
316-318 Kwun Tong Road
Kowloon, Hong Kong
During an inspection of your firm located in Liangying Town, Chaonan Borough, Shantou City, China, on December 19, 2011, through December 21, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures fluid-filled teething rings, sold under brand names such as Bright Stars and Disney Baby Einstein. 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.
These violations include, but are not limited to, the following:
1. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example, during the inspection:
a. Your firm stated that once the teething rings have been filled and sealed, the final products are sent to, (b)(4). However, your firm stated that it has not validated the (b)(4).
b. Your firm stated that the (b)(4) is a major manufacturing step for the water-filled teething rings. However, your firm stated that it has not validated the (b)(4).
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm’s (b)(4) and (b)(4), Version A/0, failed to:
a. Include a requirement for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. Additionally, none of the eleven Corrective and Preventive Action (CAPA) Reports (e.g., CAPAs dated March 3, 2011, January 8, 2011, February 1, 2010, and March 18, 2010) reviewed during the inspection included evidence of verification or validation of the corrective or preventive action prior to implementation.
b. Include a requirement for identifying the appropriate sources of quality data to analyze. Additionally, your firm stated that no data analysis has ever been performed.
3. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a).
For example, your firm’s manufacturing process to manufacture “Pretty in Pink-Chill & Teethe” water-filled teething ring consists of the following: (b)(4). However, your firm failed to maintain documented instructions, standard operating procedures, and methods that define and control the manner of production for conducting any of these processes.
4. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
a. Your firm’s (b)(4), Version A/0, requires (b)(4). However, the procedure does not require that non-conforming products found during manufacturing by production workers be documented. Your firm stated that (b)(4).
b. During the inspection, (b)(4) units of blue-heart-shape teethers, rejected during the (b)(4) process, approximately (b)(4) units of red round and heart-shape teethers rejected during the (b)(4) units of blue and red heart-shape teethers rejected during the (b)(4) process, and approximately (b)(4) units of blue and red heart-shape teethers rejected during the packaging process were observed in various rejected containers without proper identification.
5. Failure to establish and maintain procedures to prevent contamination of equipment or 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, your firm failed to establish procedures to prevent contamination of the equipment and resins used during the manufacturing of the water-filled teething ring products. The investigator observed that your firm’s (b)(4) machines used to manufacture water-filled teething rings are installed (b)(4). However, there is no door at the entrance and the molding equipment and raw materials (b)(4) are exposed to the outside environment.
6. Failure to maintain device master records, as required by 21 CFR 820.181.
For example, your firm has not established device master records for the Chill & Teethe (Model 8195) and Pretty in Pink Chill & Teethe (Model 8673) water-filled teething rings.
7. 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, as required by 21 CFR 820.184.
For example, your firm has not established written DHR procedures.
8. Failure to maintain adequate DHRs that include or refer to the location of the primary identification label and labeling used for each production unit in the device history record, as required by 21 CFR 820.184(e).
For example, none of the eleven DHRs from 2011 (e.g., (b)(4) that were reviewed during the inspection included or referred to the location of the primary identification label or labeling used for each production unit.
Given the serious nature of the violations of the Act, fluid-filled teething rings manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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. 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 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your firm’s response should be sent to Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 276757 when replying. If you have any questions about the contents of this letter, please contact: Ronald L. Swann, Branch Chief, Dental, ENT, and Ophthalmic Device Branch at 301-796-5770, or email@example.com.
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 close 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 the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Device and