Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm515175
Timestamp: 2018-12-11 07:38:35
Document Index: 275347227

Matched Legal Cases: ['§ 353', '§ 351', '§ 352', '§ 355', '§ 351', 'arts 210', '§ 201', '§ 331', 'arts 210', 'art 211']

Fallon Wellness Pharmacy, L.L.C. 2/1/16
WARNING LETTER NYK-2016-23
Mr. Peter L. Fallon, RPh, Owner
Mr. George R. Doherty, RPh, Owner
1057 Troy Schenectady Road
Dear Mr. Fallon and Mr. Doherty:
From March 2, 2015, to March 10, 2015, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Fallon Wellness Pharmacy, LLC, located at 1057 Troy Schenectady Road, Latham, NY 12110-1002.
During the inspection, investigators noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, your firm did not take remedial action when viable air samples tested positive for fungus on various dates in one of your cleanrooms during a (b)(4) cleanroom certification. In addition, your firm has no assurance the positive pressure towards the unclassified area is adequately maintained given that the entry door into the anteroom (ISO 7) could not be properly closed. Our investigators observed plastic carts, tape dispenser, supply bins, and other equipment in your aseptic areas, not intended to be used during sterile filling operations. Furthermore, your personnel were observed wearing non-sterile eye coverings, non-sterile hair bonnets, and non-sterile undergarments that were worn outside prior to entering the sterile environment. Moreover, your firm failed to demonstrate through appropriate studies that the aseptic processing areas are able to provide adequate protection of the ISO 5 area in which sterile products are processed. Therefore, your products were produced in an environment that poses a significant contamination risk.
FDA issued a Form FDA 483 to your firm on March 10, 2015. FDA acknowledges your response to the Form FDA 483, dated March 31, 2015. Based on this inspection, it appears that you produced drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
Section 503A of the FDCA [21 U.S.C. § 353a] describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP), section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)]; labeling with adequate directions for use, section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]; and FDA approval prior to marketing, section 505 of the FDCA [21 U.S.C. § 355]. Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A of the FDCA. During the FDA inspection, the investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce.
Because the drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are not the subject of approved applications, they are misbranded drugs in violation of section 502(f)(1) of the FDCA. In addition, drug products that are 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, because you manufacture and distribute a portion of your drugs without valid prescriptions for individually-identified patients, the manufacture of those drugs is also subject to FDA’s Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. FDA investigators observed significant CGMP violations at your facility, causing such drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.
You compound drug products, for which you have not obtained valid prescriptions for individually-identified patients, 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 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].
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 of the components used to make the drug and results in the drug being misbranded.
Additionally, FDA investigators observed 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 your firm did not take remedial action when viable air samples tested positive for fungus on various dates in one of your cleanrooms during a (b)(4) cleanroom certification. In addition, your firm has no assurance the positive pressure towards the unclassified area is adequately maintained given that the entry door into the anteroom (ISO 7) could not be properly closed. Our investigators observed plastic carts, tape dispenser, supply bins, and other equipment in your aseptic areas, not intended to be used during sterile filling operations. Furthermore, your personnel were observed wearing non-sterile eye coverings, non-sterile hair bonnets, and non-sterile undergarments that were worn outside prior to entering the sterile environment. Moreover, your firm failed to demonstrate through appropriate studies that the aseptic processing areas are 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.
2. Your firm failed to establish an adequate system for maintaining equipment used to control aseptic conditions (21 CFR 211.42(c)(10)(vi)).
4. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42 (c)(10)(v)).
5. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to drug product from contamination (21 CFR 211.28(a)).
FDA acknowledges your response to the Form FDA 483, dated March 31, 2015. In your response, you state that your firm operates in compliance with section 503A of the FDCA and the USP- NF General Chapter <795> and USP <797> standards, and assert that CGMPs do not apply to your firm. As discussed above, investigators noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A of the FDCA.
In your March 31, 2015, response you described certain corrective actions you took in response to the Form FDA 483 observations. Although several of your corrective actions appear adequate, your response is inadequate in that it did not include adequate documentation to verify that you have successfully implemented the corrective actions, such as standard operating procedures (SOP) or any other supporting documentation. For example, you committed to conduct smoke studies under dynamic conditions; however you did not provide a report or video describing the results of the study. In addition, your response stated you will evaluate the (b)(4) stability throughout the process, but no such evaluation or revised SOPs were included in your response.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether the drugs are compounded and distributed after receipt of a prescription for an identified individual patient. In addition, should you continue to manufacture and distribute drug products without valid prescriptions for individually-identified patients, the manufacture of such drugs would be subject to FDA's drug CGMP regulations (21 CFR Parts 210 and 211 ), among other requirements described above, and, before doing so, you should fully implement corrections that meet the minimum requirements of 21 CFR Part 211 in order to provide assurance that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.
CDR Frank Verni, RPh, Compliance Officer
If you have questions regarding any issues in this letter, please contact CDR Frank Verni at (718) 662-5702 or via email at frank.verni@fda.hhs.gov.
Ms. Erika Fallon, PharmD, Supervising Pharmacist