Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm505566
Timestamp: 2018-12-09 20:33:34
Document Index: 511316774

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

PCP LV LLC dba Pinnacle Compounding Pharmacy 5/23/16
FAX: 510-337-6859
WL-492707
Cecilia R. Ventura
PCP LV, LLC dba Pinnacle Compounding Pharmacy
c/o Maria Nutile, Esq.
1070 W. Horizon Ridge Parkway, Suite 210
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 July 10, 2015, and at the time of FDA’s inspection from July 27, 2015, to July 31, 2015, your facility, PCP LV, LLC dba Pinnacle Compounding Pharmacy, located at 4445 S. Eastern Ave, Las Vegas, NV 89119-7851, was registered as an outsourcing facility. Although, as of the date of this letter, your facility is no longer registered as an outsourcing facility, this letter discusses violations identified during the time you were registered as an outsourcing facility. Because you are no longer registered as an outsourcing facility, in the corrective action section, this letter discusses the conditions a compounded drug product must meet in order to qualify for the exemptions under section 503A of the FDCA [21 U.S.C. § 353a].
During FDA’s inspection of your facility, our investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigators noted that production occurred in the cleanroom while the positive pressure differential to the anteroom was below your specification. In addition, your environmental monitoring samples were incubated in a hallway at uncontrolled room temperature, which could potentially bias the results. The investigators also noted that your firm used an expired disinfectant and did not follow the manufacturer’s instructions to ensure an adequate contact time for your sporicidal agent. 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.
In addition, the investigators observed that you failed to meet the conditions under section 503B of the FDCA that applied to your facility at the time of the inspection and that are 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 31, 2015. FDA acknowledges receipt of your facility’s undated response, which was received on September 15, 2015.
In addition, the FDA investigators observed that your facility failed to meet the conditions of section 503B, which applied to your facility at the time of the inspection. For example, during the inspection, the FDA investigators noted that some of your facility’s drug products do not include the following information on the labeling: the date the drug was compounded; information to facilitate adverse event reporting; and the statement, “Not for resale” [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 July 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 did not meet all of the conditions in section 503B of the FDCA, they were not eligible for the exemptions under section 503B of the FDCA from the FDA approval requirements in section 505 of the FDCA, the requirement under section 502(f)(1) of the FDCA that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.[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. For example, the investigators noted that production occurred in the cleanroom while the positive pressure differential to the anteroom was below your specification. The investigators also noted that your firm used an expired disinfectant and did not follow the manufacturer’s instructions to ensure an adequate contact time for your sporicidal agent. 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.
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. The violations include, for example:
3. Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).
7. Your firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
You compounded 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)]. As stated above, because your compounded drug products did not meet all of the conditions in section 503B of the FDCA, they were not exempt from the requirements of section 502(f)(1) of the FDCA (see, e.g., 21 CFR 201.115). 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 July 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) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].
Your response to the Form FDA 483 issued at the close of FDA’s inspection of your facility, did not describe any corrective actions taken in response to the Form FDA 483 observations; it stated only that you registered as an outsourcing facility in error and that you planned to de-register. We acknowledge your firm’s September 3, 2015, de-registration.
Because your facility is no longer registered as an outsourcing facility, drug products that you produce are no longer eligible to qualify for the exemptions under section 503B of the FDCA. However, they can qualify for the exemptions under section 503A of the FDCA if they are compounded in accordance with all of the conditions of section 503A. Section 503A describes the conditions under which certain compounded human drug products are entitled to exemption from three sections of the FDCA: compliance with 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)]. Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A. In addition, there are other conditions that must be satisfied to qualify for the exemptions in section 503A of the FDCA. Please be aware that compounded drug products that qualify for the exemptions in section 503A remain subject to all other applicable provisions of the FDCA, including the requirement that the drug products are not prepared, packed, or held under insanitary conditions (section 501(a)(2)(A) of the FDCA). As described above, our investigators observed insanitary conditions during the July 2015 inspection. You should take prompt action to correct these insanitary conditions.
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 (WL-492707). Please address your reply to:
If you have questions regarding the contents of this letter, please contact William Millar, Compliance Officer at 510-337-6896 or by email at william.millar@fda.hhs.gov.