Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/qualgen-06032016
Timestamp: 2019-10-18 10:15:56
Document Index: 23236892

Matched Legal Cases: ['§ 353', '§ 353', '§ 353', '§ 355', '§ 352', '§ 360', '§ 353', '§ 351', '§ 351', '§ 353', '§353', '§353', '§ 353', '§ 355', '§ 352', '§ 360', '§ 351', '§ 351', '§ 352', '§ 331', '§ 331', '§353', '§353', '§ 331']

Qualgen - 06/03/2016 | FDA
Qualgen - 06/03/2016
Qualgen June 03, 2016
2016-DAL-WL-25
Carol Ann Tutera and Adam Stempel, Managing Members
Wild West Group, LLC
RE: Qualgen, LLC
Dear Ms. Tutera and Mr. Stempel:
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 May 23, 2014, May 8, 2015, and January 14, 2016. From August 24, 2015, to September 17, 2015, FDA investigators inspected your facility, Qualgen, LLC, 14844 Bristol Park Boulevard, Edmond, Oklahoma 70313. During the inspection, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigators observed that the ceiling tiles of your ISO 7 cleanrooms were not fully sealed, allowing ingress of unfiltered air from the surrounding non-classified area. Furthermore, the process used to render the implantable hormone pellets sterile is not adequate as evidenced by the multiple sterility failures. Moreover, the investigators also noted that your firm failed to perform adequate investigations into these sterility failures. In addition, the investigators observed that you failed to meet the conditions under section 503B of the FDCA [21 U.S.C. § 353b] that are necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain requirements under the FDCA. FDA issued a FDA 483 to your facility on September 17, 2015. FDA acknowledges receipt of your facility’s response, dated October 7, 2015, to the FDA 483; your October 9, 2015 letter notifying FDA of your voluntary recall of certain products and your October 22, 26, 28, and 30, 2015, responses to FDA’s October 20, 2015, record request.
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) of the FDCA [21 U.S.C. § 353b(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 [21 U.S.C. § 353b] are met.
FDA investigators noted that drug products that were intended or expected to be sterile 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)]. Furthermore, the FDA investigators observed significant CGMP violations at your facility, causing your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].
In addition, the FDA investigators observed that your facility failed to meet the conditions of section 503B of the FDCA [21 U.S.C. § 353b(b)]. For example, during the inspection, FDA investigators noted the following: Some of your facility’s drug products do not include the following statements on the product labels: “This is a compounded drug,” and “Not for resale.” The storage and handling instructions are also not included. Additionally, the containers for some of your drug products do not contain the following information: the route of administration. [section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]].
In addition, your facility failed to submit a report to FDA upon initial registration as an outsourcing facility in May 2014, and again in December 2014 and June 2015, 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)]].
Because your compounded drug products have not met all of the conditions in section 503B of the FDCA [21 U.S.C. § 353B], they are not eligible for the exemptions under section 503B from the FDA approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement under 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 described in section 582 of the FDCA [21 U.S.C. § 360eee-1].[2]
The FDA investigators noted that drug products compounded 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 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 investigators observed that the ceiling tiles of your ISO 7 cleanrooms were not fully sealed, allowing ingress of unfiltered air from the surrounding non-classified area.
The FDA investigators also noted CGMP violations at your facility, causing your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)]. The violations include, for example:
2. Your firm failed to have facilities used in the manufacturing, process, packaging and holding of a drug product of appropriate construction to facilitate cleaning, maintenance and proper operations. (21 CFR 211.42a)).
5. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates. (21 CFR 211.166(a)).
6. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).
7. Your firm failed to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
You compound drug products that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written 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 [21 U.S.C. § 352(f)(1)], 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 [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 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 May 2014, and again in December 2014 and June 2015, 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)]). The failure to report drugs by an entity that is registered with FDA in accordance with section 503B(b) of the FDCA [21 U.S.C. §353b(b)(2)] is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].
In your October 7, 2015 response, you describe corrective actions you have taken to address the FDA 483 observations. On October 20, 2015, FDA requested additional information regarding the status of your corrections. FDA acknowledges receipt of your responses and supplementary information on October 22, 26, 28, and 30, 2015. Although some of your proposed corrective actions appear adequate, others are deficient. For example, your October 7, 2015 response stated that the root cause for the sterility failures was the use of an unvalidated sterilization cycle. However, based on the investigation report dated October 27, 2015, it appears that your firm did not consider the sterilization cycle as a potential cause of the sterility failures. Moreover, it is unclear if the (b)(4) and implantable pellets to ensure their sterility. Your responses also did not provide sufficient detail on the blending processes, sterilization parameters, and other quality factors used in the process validation studies conducted by your firm. In addition, your responses did not provide information regarding the stability data to support the four (4) month expiration date applied to the implantable hormone pellets. Finally, your (b)(4) monitoring procedure did not include actions to be taken when established action and alert levels are exceeded.
In addition, due to the deficiencies in the practices at your outsourcing facility, your firm initiated a recall in October 2015. On October 8, 2015, FDA recommended that your firm initiate a voluntary recall of all lots of non-expired drug products intended to be sterile due to lack of sterility and quality assurance and cease sterile operations until appropriate corrective actions had been implemented.
On October 9, 2015, your firm agreed to only recall lots A001-A067, and did not agree to cease sterile operations, stating your firm had already implemented corrective actions, which were detailed in your October 7, 2015, response to the FDA 483. You indicated that the lots produced after September 1, 2015 (beginning with lot (b)(4)), were produced using a validated sterilization process and that there had not been any sterility failures in lots (b)(4).
The implemented corrective actions in reference to the observed 503B labeling deficiencies appear to be adequate.
Your firm’s response to this letter should be sent to: Dallas District Office, ATTN: John W. Diehl, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: John W. Diehl, Compliance Officer, at 214-253-5288.
John A. Foust, Pharm.D.
2920 N Lincoln Blvd, Suite A
Pharmacist Compliance Officer
Shaun P. Riney, General Manager
Qualgen, LLC
14844 Bristol Park Blvd.
Edmond, Oklahoma 70313
Ken Kotowich, Co-Owner
Charles Riney, Co-Owners
Ryan Orton, Co-Owner
3300 NW 56th Street, Suite 101