Inspections, Compliance, Enforcement, and Criminal Investigations

Fallon Wellness Pharmacy, L.L.C. 2/1/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District Office
North East Region
158-15 Liberty Ave.
Jamaica, NY 11433
           
Telephone:      718-340-7000
Facsimile:       718-662-5661 

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
WARNING LETTER NYK-2016-23
February 1, 2016
 
Mr. Peter L. Fallon, RPh, Owner
-and-
Mr. George R. Doherty, RPh, Owner
Fallon Wellness Pharmacy, LLC
1057 Troy Schenectady Road
Latham, NY 12110-1002
 
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). 
 
A. Compounded Drugs Under the 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.
 
Accordingly, the drugs you compound without valid prescriptions for individually identified patients are not entitled to the exemptions in section 503A of the FDCA.
 
B. Violations of the FDCA
 
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. 
 
Misbranded Drug Products
 
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.
 
Adulterated Drug Products
 
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.
 
FDA investigators also noted CGMP violations at your facility, causing the drug products for which you have not obtained valid prescriptions for individually-identified patients to be adulterated under section 501(a)(2)(B) of the FDCA. The violations include, for example:
 
1.    Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
 
2.    Your firm failed to establish an adequate system for maintaining equipment used to control aseptic conditions (21 CFR 211.42(c)(10)(vi)).
 
3.    Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42 (c)(10)(iv)).
 
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)).
 
6.    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)).
 
7.    Your firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (21 CFR 211.167(a)).
 
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 of the components used to make the drug and results in the drug being adulterated.
 
C.  Corrective Actions
 
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.
 
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess aseptic processing operations.  A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. 
 
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.
 
E.  Conclusion
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.  Your written notification should be addressed to:
 
CDR Frank Verni, RPh, Compliance Officer
FDA New York District Office
U.S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
 
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.
 
 
Sincerely,
/S/
Ronald Pace
District Director
New York District
 
 
cc:
 
Ms. Erika Fallon, PharmD, Supervising Pharmacist
Fallon Wellness Pharmacy, LLC
1057 Troy Schenectady Road
Latham, NY 12110-1002
 
New York State Education Department
Office of the Professions
State Board of Pharmacy
Attn: Lawrence H. Mokhiber, Executive Secretary
89 Washington Avenue
Albany, New York 12234-1000
 
New York State Department of Health
Attn: Dr. Howard A. Zucker, Acting Commissioner
Corning Tower
Empire State Plaza,
Albany, NY 12237

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