Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539578.htm
Timestamp: 2019-04-22 16:04:56+00:00

Document:
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] 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.
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.
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)]].
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.
You do not have any FDA-approved applications on file for your drug products. 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.
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.
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)].
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.
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.
 See, e.g., section 503B(a)(11) of the FDCA [21 U.S.C. § 353b(a)(11)].
 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.

References: § 353
 § 352
 § 360
 § 353
 § 351
 § 351
 §353
 §353
 § 331
 § 353
 § 321
 § 321