Inspections, Compliance, Enforcement, and Criminal Investigations
Bioteque America, Inc. 31-May-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
May 31, 2005
Mr. Denis Dorsey, President
Bioteque America, Inc.
340 East Maple Avenue
Langhorne, PA 19047
Dear Mr. Dorsey:
During an inspection of your establishment located in Langhorne, Pennsylvania, ending on March 1, 2005, our investigator determined that your firm is a specifications developer of gynecological uterine devices, such as cervical dilators, endometrial suction curettes, curelles, vabra aspirators, cytology brushes, balloon-tipped catheter sets, vaginal pessary, etc. Gynecological uterine devices are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321].
The above-stated inspection revealed that your devices are adulterated under section 501(h) of the Act [21 U.S.C. 351], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. For example:
Failure to validate the following processes conducted by your contract manufacturers: Ethylene Oxide. (EtO) sterilization cycles (sterilizers A and B that are used for sterilizing cervical dilators, endometrial suction curettes, Word/Bartholin catheters, HSG catheter sets, and Ultra catheters); sealing machines used for final packaging of sterile products; gluing/bonding operation for attachment of balloon to HSG catheter; tipping machine used for catheter component assembly [21 CFR 820.75].
You have not determined that either of your contract manufacturers in Taiwan, [redacted] and [redacted] have validated their manufacturing and/or EtO sterilization process; nor have you validated these processes yourself.
Failure to assure that final acceptance activities are conducted [21 CFR 820.80].
You do not review or maintain final acceptance records from [redacted] the contract service company who performs this function. Additionally, you do not review or maintain finished device acceptance records from your contract manufacturers as part of the device history record (DHR).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violation's noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the Food and Drug Administration (FDA). You also must promptly initiate permanent corrective and preventive action on your Quality System.
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. Additionally, no premarket submissions for Class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for the Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated without further notice. These actions include, but are not limited to, seizure; injunction, and/or civil money penalties.
We received your written responses to the FDA-483, dated March 7 and 31, 2005. However, these letters contained only general promises of corrections. Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Richard C. Cherry, Compliance Officer, at U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, PA 19106.
Thomas D. Gardine
Philadelphia District Office