Inspections, Compliance, Enforcement, and Criminal Investigations
RC Compounding Services, LLC 7/14/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
July 14, 2014
Raymond R. Carlson, Owner
RC Compounding Services, LLC
3030 Center Road
Poland, OH 44514
Dear Mr. Carlson:
Between February 5, 2013, to February 7, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, RC Compounding Services, LLC, located at 3030 Center Road, Poland, Ohio 44514. During the inspection, the investigator(s) identified serious deficiencies in your practices for producing sterile drug products which put patients at risk. For example, we observed that your firm performs aseptic processing in a room that has a wall mounted air conditioning unit and your firm does not have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Further, because your firm uses gowns that are not sterile, your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination. During the inspection, our investigators observed that you were repackaging Avastin for ophthalmic use under conditions not appropriate for ensuring the sterility of the product. An FDA Form 483 was issued to your firm on February 7, 2013.
You failed to provide a response to the observations noted in the Form FDA-483. We acknowledge your written statement of February 6, 2013, that you wish to rescind your FDA registration as a repackager. FDA also acknowledges that RC Compounding registered its facility with FDA as a 503B outsourcing facility on February 12, 2014.
A. Adulteration Charges
Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 351(a)(2)(A)], a drug is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Numerous subvisible microorganisms and other contaminants are ubiquitous in an ordinary environment.
A firm producing sterile products must take certain steps in order to ensure removal of contaminants through various controls that focus on safeguarding sterility by assuring the quality of the processing environment (e.g., surfaces, personnel, air) and the materials that go into a drug product. Otherwise, products that are intended or expected to be sterile may become contaminated during preparation and, when administered to a patient, may result in infections and/or pyrogenic responses that pose a life-threatening health risk to a patient. Failure to take these steps when producing drugs that are intended or expected to be sterile causes the drug to be prepared, packed, or held under insanitary conditions.
FDA investigators observed that your drug products that 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 these drug products to be adulterated under section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. During FDA’s inspection of your firm, the investigators observed poor aseptic practices on the part of your firm’s personnel. For example, the investigator observed that your firm performs aseptic processing in a room that has a wall mounted air conditioning unit and your firm does not have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Further, because your firm uses gowns that are not sterile, your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination. During the inspection, our investigators observed that you were repackaging Avastin for ophthalmic use under conditions not appropriate for ensuring the sterility of the product. The introduction or delivery for introduction into interstate commerce of your adulterated products, is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. It is also a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce of the components used to make the drug and results in the drug being adulterated.
B. Corrective Action
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your manufacturing operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations and design. A third party consultant with relevant sterile drug manufacturing 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 insanitary conditions identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies 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.
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. 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 FDCA, include your reasoning and any supporting information for our consideration. If the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. Your written notification should be addressed to:
Stephen J. Rabe, Compliance Officer
FDA Cincinnati District Office
U.S. Food and Drug Administration
6751 Steger Drive
Cincinnati, OH 45237-3097
If you have questions regarding any issues in this letter, please contact our office at 513-679-2700 ext. 2163.
Paul J. Teitell