Inspections, Compliance, Enforcement, and Criminal Investigations

Sincerus Florida, LLC 12/21/16

 

  

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Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-17-05
December 21, 2016
Mr. Alex Chervinsky
President and Chief Executive Officer
Sincerus Florida, LLC
3265 West McNab Road
Pompano Beach, FL 33069
 
Dear Mr. Chervinsky:
 
You registered with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b][1] on March 10, 2016. From July 12, 2016, to July 15, 2016, FDA investigators inspected your facility, Sincerus Florida, LLC, located at 3265 West McNab Road, Pompano Beach, FL 33069. During the inspection, the investigators observed that you failed to meet the conditions under section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain requirements under the FDCA. FDA issued a Form FDA 483 to your facility on July 15, 2016. We acknowledge receipt of your facility’s response, dated July 25, 2016.
 
Based on this inspection, it appears your facility is producing drugs that violate the FDCA. 
 
A. Compounded Drugs under the FDCA
 
The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. Title I of the DQSA, the Compounding Quality Act (CQA), added a new section 503B to the FDCA. Under section 503B(b), a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility can qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the    
 
FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.
 
An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.
 
B. Conditions of 503B
 
Your facility does not meet the definition of “outsourcing facility” in section 503B of the FDCA, which defines an outsourcing facility, in part, as a facility that is “engaged in the compounding of sterile drugs.”  From the time of your firm’s registration as an outsourcing facility until the time of our inspection, your facility has produced only non-sterile drug products. 
 
In addition, your facility failed to submit a report to FDA upon registering as an outsourcing facility in March 2016, identifying the drug products that you compounded during the previous 6-month period [section 503B(b)(2) of the FDCA [21 U.S.C. §353b(b)(2)]].
 
Our investigators also noted that some of your facility’s drug products do not include the following on the label: the date the drug was compounded, dosage form, storage and handling conditions, a list of inactive ingredients, and the statement, “Office Use Only” [section 503B(a)(10)(A) of the FDCA [21 U.S.C. §353b(a)(10)(A)]].
 
C. Violations of the FDCA
 
Because your facility does not meet the definition of an outsourcing facility in section 503B and because your compounded drug products have not met all of the conditions in section 503B, your drug products are not eligible for the exemptions under section 503B from the FDA approval requirements in section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.[2] 
 
Specific violations are described below.
 
Unapproved New Drug Products
 
You do not have any FDA-approved applications on file for your drug products.[3] Under sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced 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. 
 
Misbranded Drug Products
 
You prepare drug products that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, and 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) of the FDCA (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. 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 and results in the drug being misbranded.
 
Failure to Report Drugs
 
As noted above, your facility failed to submit a report to FDA upon initial registration as an outsourcing facility in March 2016, identifying the drug products that you compounded during the previous 6-month period. (Section 503B(b)(2) of the FDCA). The failure to report drugs by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].
 
C. Corrective Actions
 
In your July 25, 2016, letter you described certain corrective actions you have taken or are planning to take in response to the Form FDA 483 inspectional observations. The corrective actions you have taken to correct the labeling observations appear to be adequate.
 
However, as previously stated, to meet the definition of an outsourcing facility, your facility must be engaged in the compounding of sterile human drugs; otherwise, none of the products produced at your facility will qualify for the exemptions provided in section 503B of the FDCA. We acknowledge your statement that you intend to start compounding sterile products in September 2016 or earlier. We will verify that you are compounding sterile human drug products at a future inspection. For more information, we direct you to our final guidance, Guidance For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434171.pdf.
 
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, 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 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 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 completed.  Your written notification should refer to the Warning Letter Number above 17-05. Please address your reply to Salvatore N. Randazzo, Compliance Officer, at the address above.
 
If you have questions regarding the contents of this letter, please contact Mr. Randazzo by phone at (407) 475-4712 or by email at Salvatore.Randazzo@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District
 

[1] See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).
[2] See, e.g., section 503B(a)(11) of the FDCA [21 U.S.C. § 353b(a)(11)].
[3] The specific products made by your firm are drugs within the meaning of section 201(g) of the Act, [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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