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Nutrishare Inc MARCS-CMS 543730 —

Recipient Name
Mr. Rodney J. Okamoto
Nutrishare Inc

9850 Kent Street
Elk Grove, CA 95624
United States

Issuing Office:
Detroit District Office

United States



Black HHS-Blue FDA Logo


Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax: (313) 393-8139 



January 16, 2018
Case#: 543730
SIGNATURE REQUIRED                                                        CORRECTED COPY
Mr. Rodney J. Okamoto
Owner and President
Nutrishare, Inc.
9850 Kent Street
Elk Grove, CA 95624
Dear Mr. Okamoto:
From May 22, 2017, to May 26, 2017, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Nutrishare, Inc., located at 11020 Plantside Drive, Louisville, KY 40299-6105. During the inspection, the investigator noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.  
FDA issued a Form FDA 483 to your firm on May 26, 2017. FDA acknowledges receipt of your facility’s response, dated June 19, 2017. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug and Cosmetic Act (FDCA).
A.    Violations of the FDCA
Adulterated Drug Products
The FDA investigator noted that drug products 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 FDCA [21 U.S.C. § 351(a)(2)(A)]. For example, the investigator observed that non-sterile wipes were used to clean the ISO 5 hoods and an employee introduced exposed skin into an ISO 5 hood during the production of a sterile drug product.
Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is 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 and results in the drug being adulterated.
B.    Corrective Actions
In your response to the Form FDA 483 inspectional observations, dated June 19, 2017, you indicated that you are in compliance with USP 797. However, your response does not appear to address the insanitary conditions found in your facility. For example, your response indicated that you will continue to use non-sterile wipes to clean and disinfect the ISO 5 hoods. The use of non-sterile wipes could spread microbial spores in the critical areas. In addition, your response did not address the poor aseptic techniques of your personnel. The introduction of exposed skin into an ISO 5 environment may cause the sterile drug product to become contaminated.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A [21 U.S.C. §353a].
Should you compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug current good manufacturing practices (CGMP) regulations.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems.  In particular, this review should assess your aseptic processing operations.  A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.
C.    Conclusion
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 that 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 fifteen (15) 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 you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
In addition, the Agency is concerned about the presence of the two (2) wall-mounted units in the (b)(4) room, which appear to be stand-alone air conditioning units; this equipment is potentially a source of microbial contamination. In your response, please describe the equipment, and indicate how the equipment is used in the (b)(4) room. Your response should include sufficient documentation such as certification reports, photographs, cleaning records or any other records to allow the Agency to evaluate the controls in place in to minimize the microbial contamination of your ISO classified areas.
 Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.
            Attn:    Eric M. Mueller, Compliance Officer
                        U. S. Food and Drug Administration
                        Division of Pharmaceutical Quality Operations III
Refer to the Unique Identification Number (Case# 543730) when replying. If you have questions regarding the contents of this letter, please contact Mr. Mueller by phone at (402) 331-1101.
Art O. Czabaniuk
Program Division Director
Division of Pharmaceutical Quality Operations III
Gregory Killmeier, Pharmacist
Nutrishare, Inc.
11020 Plantside Drive
Louisville, KY 40299 
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