Inspections, Compliance, Enforcement, and Criminal Investigations

Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy 2/3/16

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-16-08
February 3, 2016
 
Mr. Jeffrey Steele and Mr. Milton Larrea, Owners
Infusion Systems of SW Florida Inc., dba Myerlee Pharmacy
1826 Boy Scout Drive
Fort Myers, FL 33907
 
 
Dear Mr. Steele and Mr. Larrea:
 
From December 1, 2014, to December 22, 2014, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Infusion Systems of SW Florida, Inc. (dba Myerlee Pharmacy), located at 1826 Boy Scout Drive, Fort Myers, FL 33907. 
 
During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. The investigator also noted that your firm produces Domperidone drug products. Domperidone is not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, nor is it a component of an FDA-approved human drug product, and it does not appear on a list developed by the Secretary under section 503A(b)(1)(A)(i)(III) of the Federal Food Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a (b)(1)(A)(i)(III)]. In addition, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigator observed an operator with exposed forearms and operators resting their forearms inside the ISO 5 areas (Laminar Flow Hoods) during aseptic processing of sterile drug products. In addition, personnel did not sanitize the component bags (e.g., bags containing vials, syringes and filters) with (b)(4) prior to placing them inside the ISO 5 areas. Furthermore, our investigator noted that your firm failed to demonstrate through appropriate studies that your hoods 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. 
 
A Form FDA-483 was issued to your firm on December 22, 2014. Based on this inspection, it appears that you are producing drugs that violate the 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. 
 
During the FDA inspection, the investigator 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.
 
The drug products you compound with domperidone, which is not the subject of an applicable USP or NF monograph, not a component of an FDA-approved human drug, and does not appear on a list developed by the secretary under section 503A(b)(1)(A)(i)(III) of the FDCA, are also not entitled to the exemptions in section 503A of the FDCA.
 
In addition, we remind you that there are a number of other conditions that must be satisfied to qualify for the exemptions in section 503A of the FDCA.[1]
 
B.  Violations of the FDCA
 
The drug products your firm manufactures and distributes without valid prescriptions for individually-identified patients are misbranded drugs in violation of section 502(f)(1) of the FDCA. Furthermore, the Domperidone products you produce are also 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 whereby they may have been 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 such drugs is subject to FDA’s CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. The FDA investigator 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. 
 
Misbranded Drug Products
 
You compound Domperidone products and 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 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 and results in the drug being misbranded.
 
Adulterated Drug Products
 
Additionally, the FDA investigator noted the drug products 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 investigator observed an operator with exposed forearms and operators resting their forearms inside the ISO 5 areas (Laminar Flow Hoods) during aseptic processing for sterile drug products. In addition, personnel did not sanitize the component bags (e.g., bags containing vials, syringes and filters) with (b)(4) prior to placing them inside the ISO 5 areas. Furthermore, our investigator noted that your firm failed to demonstrate through appropriate studies that your hoods 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. 
 
The FDA investigator 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. Failure 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)].
  1. Failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas [21 CFR 211.42(c)(10)(iv)].
  1. Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].
  1. Failure to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination [21 CFR 211.28(a)].
  1. 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)].
  1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release [21 CFR 211.165(a)].
  1. 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)].
 
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 and results in the drug being adulterated.
 
D.  Corrective Actions
 
We acknowledge receipt of your response to the Form FDA 483, dated January 7, 2015, in which you stated that your firm “ceased all office use sterile compounding,” and referenced your purported compliance with the United States Pharmacopeia (USP)-National Formulary (NF) General Chapter <797> Pharmaceutical Compounding--Sterile Preparations. Your response also describes certain corrective actions you took to address the Form FDA 483 observations. 
 
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. Your response is inadequate as the corrective actions do not adequately address the observed insanitary conditions at your facility. Specifically, your response did not indicate an estimated timeframe for the implementation of your proposed corrective actions or include appropriate interim actions to address the deficiencies. For example,your response did not provide information to indicate which, if any, sporicidal agent will be used. In addition, you indicated that the gowning SOP will be reviewed with all compounding staff to assess proper gowning procedures and hand hygiene, however you did not indicate when this corrective action plan is to be implemented.   
 
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.
 
During FDA’s next inspection of your facility, we will evaluate the adequacy of the steps you have taken to comply with all requirements of federal law and FDA regulations.    
 
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 your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. 
 
In addition, you should also correct the violations of section 502(f)(1) of the FDCA, noted above.
 
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. FDA may re-inspect to ensure that your firm complies with all requirements of federal law and FDA regulations. 
 
Within fifteen (15) 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 (15) working days, state the reason for the delay and the time within which you will complete the correction. Your written response should be sent to:
 
Carla A. Norris, Compliance Officer
FDA Florida District Office
U.S. Food and Drug Administration
555Winderley Place, Suite 200
Maitland, FL 32751
 
If you have questions regarding any issues in this letter, please contact Ms. Norris via email at carla.norris@fda.hhs.gov or by phone at 407-475-4730.
 
 
Sincerely,
/S/ 
Susan Turcovski
District Director
Florida District


[1]For example, section 503A also addresses anticipatory compounding, which includes compounding (not distribution) before receipt of a valid prescription order for an individual patient. We are not addressing anticipatory compounding here.

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