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September 2, 2020

WARNING LETTER

WL #604449

Dear Ms. Bryant-Wimp:

From September 10, 2018, to September 19, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Accurate Rx Pharmacy Consulting LLC dba Accurate Rx Pharmacy, located at 103 Corporate Lake Drive, Suite B, Columbia, MO 65203. During the inspection, the investigator 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 September 19, 2018. FDA acknowledges receipt of your facility’s written response, dated October 2, 2018. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Compounded Drug Products Under the FDCA

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 practice (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)].¹ Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigator 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.
For example,

1. The investigators observed your facility design allows the influx of lower quality air into an area intended to have higher quality air in that:

  a. Your ISO5-classified workstation, used to produce drug products purporting to be sterile, is located and operated in a non-classified area.
  b. The non-classified room housing the ISO5-classified workstation contains a ductless air conditioning unit which is mounted to the wall, directly above the ISO5-classified workstation. This unit, when operated, would circulate non-HEPA filtered air throughout the room and possibly into the ISO5-classified space, presenting a direct contamination risk to drug products.

2. Your practices for cleaning and disinfecting are deficient in that:

  a. You use non-sterile wipes and non-sterile cleaning agents to clean the ISO5-classified area, both of which may introduce microbial contamination.
  b. You do not use a sporicidal cleaning agent to clean the ISO5-classified area.

3. Your routine environmental monitoring (EM) is inadequate in that the environmental samples are collected following cleaning of the surfaces. Consequently, there is no assurance that the EM testing results are representative of actual environmental conditions.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, 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 adulterated.

C. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483, dated October 2, 2018. Although several of your proposed corrective actions appear adequate, others are deficient. For example,

1. Regarding the operation of an ISO5-classified workstation in a non-classified room to produce drug products intended to be sterile, your response notes your intent to (b)(4) during cleaning. However, this does not adequately mitigate the fundamental contamination risk associated with producing drug products intended to be sterile, in an ISO5-classified workstation located in a non-classified area.

2. Regarding the operation of a ductless air conditioning unit in close proximity to the ISO5-classified workstation used to produce drug products intended to be sterile, your response provides instructions for the maintenance of the unit, including procedures for its cleaning and filter replacement. However, because the “cleanroom,” which houses both this wall-mounted air conditioning unit and the ISO5-classified workstation is non-classified, and it is not subject to routine particle counts or certification under dynamic conditions (i.e. while the air conditioner is running), this does not adequately mitigate the fundamental contamination risk associated with producing drug products intended to be sterile, in an ISO5-classified workstation located in a non-classified area.

Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

D. 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 (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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.

Please address your reply via email to: [email protected]

Attention: Tina M. Pawlowski, Compliance Officer
U.S. Food and Drug Administration
Division of Pharmaceutical Quality Operations III

Your written notification should refer to the Warning Letter Number above (#604449). If you have questions regarding the contents of this letter, please contact Tina M. Pawlowski at (313) 393-8217.

Sincerely,
/S/

Art O. Czabaniuk
Program Division Director
Division of Pharmaceutical Quality Operations III
 

Cc: Randy Broyles
Vice President, Operations at Diplomat Specialty Infusion Group
7167 East Kemper Road
Cincinnati Ohio 45249

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1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.