- Diabetes Corporation of America
- Issuing Office:
- New Orleans District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New Orleans District|
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
June 3, 2016
WARNING LETTER NO. 2016-NOL-06
UNITED PARCEL SERVICE
Delivery Signature Requested
Hoy D. Allen, CEO
Diabetes Corporation of America
233 Bedford Way
Franklin, Tennessee 37064-5527
Dear Mr. Allen:
From August 11-14 and 17-20, 2015, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Diabetes Corporation of America, located at 233 Bedford Way, Franklin, Tennessee.
During the inspection, the FDA investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators noted your firm did not depyrogenate the container closures of injectable finished drug products. Our investigators observed sterilized glass vials stored in your anteroom without an established hold time to ensure these items remain sterile. Our investigators also noted thatyour firm has no assurance of the sterility of multi-use solutions used to produce injectable drug products without a subsequent sterilization step. Your firm did not use a sporicidal agent to disinfect the aseptic processing area. Furthermore, your firm failed to demonstrate through appropriate studies that your aseptic processing area is able to provide adequate protection of the ISO 5 area in which sterile products are processed. Therefore, your products may have been produced in an environment that poses a significant contamination risk.
Based on this inspection, it appears you are producing drugs which violate the Federal Food, Drug, and Cosmetic Act (the Act).
A. Violations of the Act
Adulterated Drug Products
FDA investigators observed drug products in your facility which were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under Section 501(a)(2)(A) of the Act [21 United States Code (U.S.C.) 351(a)(2)(A)]. For example, FDA investigators observed:
1. Your firm did not depyrogenate the container closures of injectable finished drug products. Furthermore, our investigators observed sterilized glass vials stored in your anteroom without an established hold time to ensure that these items remain sterile.
2. Your firm has no assurance of the sterility of multi-use solutions used to produce injectable drug products. Puncturing a container compromises the integrity of the container closure system, and each puncture increases the chances of contamination.
3. Your firm did not use a sporicidal agent to disinfect the aseptic processing area.
4. Your firm did not demonstrate through appropriate studies that your aseptic processing area is able to provide adequate protection of the ISO 5 area in which sterile products are processed. Therefore, your products may have been produced in an environment that poses a significant contamination risk.
B. Corrective Actions
We acknowledge your response, dated September 1, 2015, to the Form FDA 483 Inspectional Observations, issued to you on August 20, 2015. Although several of your proposed corrective actions appear adequate, others are deficient or cannot be evaluated because of a lack of supporting documentation. For example, in response to our observation of inadequate processing of containers and closures, you proposed to use dry heat for sterilization and depyrogenation of your glassware. You provided your updated SOP entitled, (b)(4) However, you did not provide the parameters (e.g., temperature and duration) for the dry heat depyrogenation process. In addition, you did not provide any corrective action regarding the depyrogenation of stoppers.
In response to our observation of using multi-use solutions for producing finished drug products without a subsequent sterilization step, you stated that “(b)(4).” However, your response does not indicate how you will ensure the sterility of the finished product after multiple punctures to the same container.
In your response, you stated you have changed your cleaning policy to include the disinfection of your ISO 5 hood with a sporicidal agent. However, you did not specify the required contact time for this disinfectant. In addition, the documentation provided in your response does not confirm that dynamic smoke studies were performed for the ISO 5 hood. Please note that smoke studies shall be conducted in the ISO 5 classified area to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions.
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess aseptic processing operations. A third party consultant with relevant aseptic processing expertise could be useful in conducting this comprehensive evaluation.
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including 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.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed. Your written notification should be addressed to:
Kari L. Batey, Compliance Officer
U.S. Food and Drug Administration
404 BNA Dr., Bldg. 200, Ste. 500
Nashville, TN 37217-2597
If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808 or via email at firstname.lastname@example.org.
Ruth P. Dixon
New Orleans District