Inspections, Compliance, Enforcement, and Criminal Investigations
Proportional Technologies, Inc 3/31/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
March 31, 2011
RETURN RECEIPT REQUESTED
Jeffrey L. Lacy, Ph.D.
Owner and President
Proportional Technologies, Inc.
8022 El Rio Street
Houston, TX 77054
Dear Dr. Lacy:
During our July 15 to August 3, 2010 inspection of your facility, Proportional Technologies, Inc., located at 8040 El Rio Street, Houston, Texas, an investigator from the Food and Drug Administration (FDA) identified significant deviations from the Positron Emission Tomography (PET) compounding standards and the official monographs of the United States Pharmacopeia (USP). These violations cause your PET radiopharmaceutical to be adulterated within the meaning of section 501 (a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S. C. § 351 (a)(2)(C)] in that the methods used in, or the facilities or controls used for, its compounding, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, the PET compounding standards and the official monographs of the USP.
Specific violations observed during the inspection include, but are not limited, to the following:
1. Your firm has failed to verify the sterilization process of assembly components and has also failed to periodically verify the sterilizer performance.
For example, your firm has failed to adequately validate the sterilization of your microgenerator and the product contact tubing used in the generator. The use of a color indicator does not provide assurance of sterilization for the materials in the autoclave.
2. Your firm has failed to demonstrate that your PET radiopharmaceutical for parenteral administration is sterile and free of endotoxins, as determined by sterility and endotoxin testing. For example:
a. Your firm's standard operating procedure, SP06-004A, "Sterility Testing of Generator Eluant," does not include a suitability testing procedure (e.g., validation of microbial recovery from eluant) to demonstrate that the eluant does not interfere with potential microbial recovery.
b. Your firm has not conducted growth promotion testing to verify the suitability of the incoming (b)(4) and (b)(4) media used for product sterility testing.
3. Your firm has failed to conduct finished product assembly in an aseptic hood with an air cleanliness rating of (b)(4) For example:
a. Your firm has failed to use sterile cleaning agents to disinfect the aseptic hood used to aseptically manufacture your sterile product. Although your firm uses (b)(4) to clean the interior of your aseptic hood, your firm does not have any data to demonstrate that the (b)(4) is sterile (e.g., (b)(4) is not filter-sterilized prior to use) and adequate for its intended use.
b. Your firm has not conducted environmental monitoring of viable and nonviable particulates for your aseptic hood. In addition, your firm does not have any evidence that the aseptic hood has been certified to (b)(4) conditions since March 2008.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute 62CU-ETS manufactured at this facility, and provide the date and reason you ceased production.
Your reply should be sent to the following address: Thao Ta, Compliance Officer, U.S. Food and Drug Administration, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.
If you have any questions about the content of this letter, please contact Mr. Thao Ta at (214) 253-5217.
Reynaldo R. Rodriguez, Jr.
Dallas District Director