Inspections, Compliance, Enforcement, and Criminal Investigations

University Rx Specialties Inc 9/28/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

 

WARNING LETTER
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 28, 2016                                                                                       
WL 51-16
Joseph Grasela, R.Ph., Owner
University Rx Specialties Inc., dba University Compounding Pharmacy
1875 3rd Avenue.
San Diego, CA 92101-2604
 
Dear Mr. Grasela:
 
From August 13, 2015, to September 21, 2015, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, University Rx Specialties Inc., dba University Compounding Pharmacy, located at 1875 3rd Avenue, San Diego, CA 92101-2604. 
 
During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing.  In addition, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, your firm failed to use sterile wipes and used a non-sterile disinfectant as part of the disinfection program for the aseptic processing areas. In addition, the investigator noted that on several occasions there was a minimal pressure differential between your anteroom and the unclassified area. Furthermore, your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile products are processed. Therefore, your products may be produced in an environment that poses a significant contamination risk.
 
FDA issued a Form FDA 483 to your firm on September 21, 2015. FDA acknowledges receipt of your firm’s responses to the Form FDA 483, dated October 5, 2015, November 3, 2015, and April 29, 2016.
 
Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
A. Compounded Drugs Under the FDCA
 
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].[1] Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A. 
 
During the FDA inspection, the investigator observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce. Because these drug products do not meet the conditions of section 503A, they are not entitled to the exemptions in section 503A of the FDCA.
 
B. Violations of the FDCA
 
Because the drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are not the subject of approved applications, they are unapproved new drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) of the FDCA, respectively.
 
In addition, drug products that are intended or expected to be sterile drug products were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or rendered injurious to health, causing them to be adulterated within the meaning of section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. 
 
Unapproved New Drug Products
 
You do not have any FDA approved applications on file for the drug products for which you have not obtained valid prescriptions for individually-identified patients.[2] Under sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FDCA, a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Your marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
 
Misbranded Drug Products
 
You compound drug products for which you have not obtained valid prescriptions for individually-identified patients that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FDCA, and they are not exempt from the requirements of section 502(f)(1) (see, e.g., 21 CFR § 201.115). The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA [21 U.S.C. § 331(a)]. 
 
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 of the components used to make the drug and results in the drug being misbranded.
 
Adulterated Drug Products
 
The FDA investigator observed that drug products in your facility 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 the drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the FDA investigator observed that your firm failed to use sterile wipes and used a non-sterile disinfectant as part of the disinfection program for the aseptic processing areas. In addition, the investigator noted that on several occasions there was a minimal pressure differential between your anteroom and the unclassified area. Furthermore, your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile products are processed. 
 
Under section 301(a) of the FDCA, 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 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.
 
C. Corrective Actions
 
We acknowledge your responses to the Form FDA 483 inspectional observations, dated October 5, 2015, November 3, 2015, and April 29, 2016. Your proposed corrective actions appear adequate, but cannot be fully evaluated as your firm did not provide sufficient supporting documentation. For example, you stated that the pressure differential between your anteroom and the unclassified area has been corrected, but you did not provide any supporting documentation.
 
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether the drugs are compounded and distributed after receipt of a valid prescription for an identified-individual patient. In addition, should you continue to manufacture and distribute drug products that do not meet the conditions of section 503A – such as drug products without valid prescriptions for individually-identified patients – the manufacture and distribution of such drugs would be subject to FDA’s drug CGMP regulations (21 CFR 210 and 211), and before doing so, you should fully implement corrections that meet the minimum requirements of 21 CFR Part 211, in order to provide assurance that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity. As indicated above, such drug products would also be subject to new drug approval requirements in section 505 and the requirement to be labeled with adequate directions for use in section 502(f)(1), among other requirements of the FDCA.
 
In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA, as amended by the Food and Drug Administration Safety and Innovation Act (Pub.L. 112-144, Title VII, section 711).  We note that you have chosen to hire a contract testing laboratory to perform some of the required testing of your finished drug products.  If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant.  Regardless of whether you rely on a contract facility, you are responsible for assuring that your compounded drug products are neither adulterated nor misbranded.  See 21 CFR 210.1(b), 21 CFR 200.10(b).
 
D. 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 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 (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. 
 
Your written notification should be addressed to:
 
Kelly Sheppard, Director
Compliance Branch
U.S. Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, California 92612-2506
 
If you have questions regarding any issues in this letter, please contact Ms. Mariza Jafary, Compliance Officer via email at Mariza.Jafary@fda.hhs.gov or by phone at 949-608-2977.
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
Cc:      
David M. Mazzera, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, California 95899-7435
 


[1] We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.
[2] The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S. C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. §321(p)] because they are not generally recognized as safe and effective for their labeled uses.

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