Inspections, Compliance, Enforcement, and Criminal Investigations
H & H Wholesale Services, Inc. 3/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
Telephone: 313-393-81 00
March 27, 2012
VIA UNITED PARCEL SERVICE
Howard B. Goldman
H&H Wholesale Services, Inc.
1099 Rochester Road
Troy, Michigan, 48083
Dear Mr. Goldman:
During an inspection of your firm located in Troy, Michigan, on October 25, 2011, through December 16, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures OneTouch Ultra 50's Glucose Test Strips, One Step Urine Pregnancy Tests Strips, and One Step THC Urine Test Strips. 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 they 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) 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 establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm has not established a procedure documenting how complaints will be received, reviewed, and evaluated.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm does not have established procedures documenting how contractors are evaluated and selected, nor have quality requirements been established for suppliers. For example, your firm has not evaluated the broker utilized to hold imported One Touch Ultra 50's Glucose Test Strips until release. The broker's warehouse fails to have environmental controls capable of storing the One Touch Ultra 50's Glucose Test Strips within or under the maximum temperature requirement of 86°F, according to product labeling. The broker's warehouse manager indicated that temperatures exceeded 110°F and 120°F on numerous occasions when product was stored in the warehouse during the summer of 2011.
3. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm did not have documentation for the acceptance activities for the One Touch Ultra 50's Glucose Test Strips, One Step HCG Urine Pregnancy Test Strips, and One Step THC Test Strips when they are received at your facility. For example, your firm could not provide documentation for acceptance requirements or activities for the following:
a. (b)(4) shipments of One Touch Ultra 50's Glucose Test Strips received between 10/2010 and 10/2011;
b. At least (b)(4) kits of One Step HCG Urine Pregnancy Test Strips received between 10/1/2010 and 9/30/2011; and
c. Approximately (b)(4) kits of One Step THC Test Strips received between 10/1 /2010 and 12/7/2011.
4. 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 and the requirements of this part, as required by 21 CFR 820.184. Specifically, your firm has not defined, documented, and implemented procedures to define how DHRs are to be created and maintained.
For example, DHRs have not been created for the following medical devices shipped by your firm:
a. One Touch Ultra 50's Glucose Test Strips. Specifically, your firm received, relabeled, and distributed approximately (b)(4) boxes of One Touch Ultra 50's Glucose Test Strips between 10/1/2010 and 12/7/2011. However, your firm did not document what sticker was applied in each shipment or if the sticker used was approved for use by your firm's management.
b. One Step HCG Urine Pregnancy Test Strips. Specifically, your firm received, repackaged, and distributed approximately (b)(4) kits of One Step HCG Urine Pregnancy Test Strips received between 10/1/2010 and 9/30/2011. However, your firm did not document how these kits were shipped, including any documentation of approved labeling, or if these kits were assembled in accordance with a device master record.
c. One Step THC Test Strips. Your firm received, repackaged, and distributed approximately (b)(4) kits of One Step THC Test Strips between 10/1/2010 and 12/7/2011. However, your firm did not document how these kits were shipped, including any documentation of approved labeling, or if these kits were assembled in accordance with a device master record.
5. Failure to establish a quality plan that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured, as required by 21 CFR 820.20(d). Specifically, your firm has not created a quality plan for the devices it manufactures or defined how the requirements for quality will be met.
Our inspection also revealed that your firm's glucose, pregnancy, and THC test strip kit 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 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm does not have a documented procedure for evaluating and investigating complaints to determine how medical device reporting to the Food and Drug Administration is to be accomplished.
Our inspection also revealed that your firm 's devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for the devices fails to bear adequate directions for use for the purposes for which they are intended. For example, your firm does not provide package inserts for the pregnancy and THC test kits. Those package inserts are required in order to provide adequate directions for use.
Additionally, our inspection revealed that your firm's devices are misbranded under section 502(b) of the Act, 21 U.S.C. § 352(b), in that the device is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor. For example, your firm does not list the manufacturer or distributor's name and address on the pregnancy and THC test kits.
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: Catherine V. Quinlan, Compliance Officer, Food and Drug Administration at 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the contents of this letter, please contact: Ms. Quinlan at (313) 393-8153.
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.
Glenn T. Bass
Detroit District Office