Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maplerose-enterprises-llc-dba-pencol-pharmacy-520095-08022017
Timestamp: 2019-07-21 11:17:10
Document Index: 782826355

Matched Legal Cases: ['§ 353', '§ 351', '§ 351', 'arts 210', '§ 351', '§ 352', '§ 331', '§ 351', '§216', '§ 355']

Maplerose Enterprises, LLC, dba Pencol Pharmacy - 520095 - 08/02/2017 | FDA
Maplerose Enterprises, LLC, dba Pencol Pharmacy - 520095 - 08/02/2017
Maplerose Enterprises, LLC, dba Pencol Pharmacy MARCS-CMS 520095 — Aug 02, 2017
Maplerose Enterprises, LLC, dba Pencol Pharmacy
August 2, 2017 CMS# 520095
Tony E. Jones, Owner
Maple Rose Enterprises, Inc. dba Pencol Compounding Pharmacy
1325 S Colorado Boulevard, Suite B-024
Denver, Colorado 80222-3303
From August 8, 2016, to August 22, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, located at 1325 S Colorado Boulevard, Suite B-024, Denver, Colorado 80222-3303. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA. In addition, the investigators noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.
FDA issued a Form FDA 483 to your firm on August 22, 2016. FDA acknowledges receipt of your firm’s written response, dated September 12, 2016. Based on this inspection, it appears that you produced drug products that violate the FDCA and your written response does not fully address our concerns as discussed below.
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) ad 355(a)].[1] Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.
The FDA investigators noted that drug products 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 your firm used a non-sterile cleaning and disinfecting agent on the ISO 5 classified work surfaces, and that your sporicidal agent’s contact time was insufficient to ensure efficacy. In addition, investigators observed a gap in the ceiling tile located above of the aseptic production area. The investigators also found that your firm did not perform post-filtration integrity testing of the filter used to sterilize drugs intended to be sterile according to the manufacturer’s recommendation. Also, your firm failed to demonstrate, through appropriate studies, that your hoods are able to provide adequate protection of the ISO 5 areas where sterile products are processed.
Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible 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 included, for example:
Your firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).
The ineligible drug products you compounded are intended for conditions 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.[2] Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]. As previously stated, 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.
We have reviewed your firm’s response to the Form FDA 483. We cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation.
In response to Observation 1 pertaining to the raised ceiling tile, you did not identify or implement any actions to ensure that gaps in ceiling tiles above aseptic processing areas would be addressed.
In response to Observation 4 pertaining to disinfectants, you did not indicate whether any sporicidal agent would continue to be used on the surfaces of the ISO 5 production equipment, and have not provided documentation to justify a 10 minute contact time for Spor-Klenz.
In response to Observation 4 pertaining to autoclaved beakers, utensils, and stir equipment used in the production of injectables which were inadequately depyrogenated, your response does not specify the cycle parameters nor does it include any documentation (such as batch records, procedures, and printouts from the (b)(4)).
In response to Observation 5 pertaining to smoke studies, the videos included in your response were not performed under dynamic conditions as no operators were observed simulating aseptic manipulations.
Please be aware that section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)] concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition for receipt of a prescription for an identified individual patient prior to compounding and distributing drug products.
As explained above, receipt of valid prescriptions for individually-identified patients is a condition of section 503A, which your firm failed to meet for a portion of the drug products you produced. In addition, we note that between May 2016 and July 2016 you compounded and distributed cisapride products. Drug products compounded using cisapride are not eligible for the exemptions provided by section 503A of the FDCA because cisapride appears on the withdrawn or removed list at 21 CFR §216.24 (effective November 7, 2016). Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of sections 505 and 502(f)(1) of the FDCA [21 U.S.C. §§ 355(a) and 352(f)(1)] and fully implement corrections that meet the minimum requirements of the CGMP regulations.[3]
Your written notification should refer to the Warning Letter Number above (CMS# 520095) and should be sent to:
Director, Office of Pharmaceutical Quality Operations, Division IV
If you have questions regarding drug product issues in this letter, please contact Dr. Dionne via email at Matthew.Dionne@fda.hhs.gov or by phone at 303-236-3064 and reference unique identifier 520095.