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	Office of Pharmaceutical Quality Operations, Division 2 4040 North Central Expressway, Suite 300 Dallas, TX 75204-3158

WARNING LETTER
CMS #547494

March 1, 2018

UPS OVERNIGHT MAIL

Mr. Robert Fahlman, Chief Executive Officer
Preferred Homecare (Corporate Office)
4601 East Hilton Ave., Suite 100
Phoenix, Arizona 85034

Dear Mr. Fahlman:

From June 27, 2017, to July 11, 2017, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Park Infusioncare LP dba Preferred Homecare, located at 13621 Inwood Road, Suite 420, Dallas, Texas 75244-4645. 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 July 11, 2017. FDA acknowledges receipt of your facility’s response, dated August 1, 2017. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Violations of the FDCA

Adulterated Drug Products

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. For example,

1.    Dead insects were observed in three separate locations of your pharmacy, including the area where aseptic production is performed.

2.    Residue was observed in three locations in your ISO 7 cleanroom, including the areas of both an ISO 5 hood and an (b)(4) where your technicians perform sterile production operations.

3.    Your firm used non-sterile wipes and a non-sterile disinfectant as part of your disinfection program for the aseptic processing area.

4.    Poor aseptic practices were observed at your firm. An aseptic operator was observed leaving the cleanroom to retrieve supplies from an anteroom and then returned to the aseptic production area to resume aseptic operations without changing or sanitizing gloves. In addition, an aseptic operator was observed donning sterile gloves improperly by touching the outside of the gloves with bare hands.

5.    Your media fill studies were not performed under the most challenging or stressful conditions of aseptic processing. Therefore, your products may be produced in an environment that poses a significant contamination risk.

B. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483.

Regarding the insanitary conditions observed during the inspection, some of your corrective actions appear to be adequate. However, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include adequate supporting documentation:

1.    Regarding the residue observation, you stated that ISO 5 Hood (b)(4) has been taken out of service and removed from the facility. In addition, you stated that you have cleaned, disinfected, and removed the residue from the contact surface grating of your (b)(4). However, you did not provide supporting documentation (e.g., photos) to demonstrate that the residue has been effectively removed.

2.    Your firm committed to “replace all non-sterile disinfectants, pads, and wipes with sterile products.” However, you did not provide supporting documentation (e.g., purchase orders, certificates of analysis, product labels) to demonstrate that these non-sterile items have been replaced.

3.    You stated that you will revise your current procedures to incorporate “processes performed when using the (b)(4) for Total Parenteral Nutrition (TPN) manipulations.” However, supporting documentation, such as revised procedures and records of completed media fill simulations, was not provided for our review.

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 [21 U.S.C. § 353a].

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 processing expertise should assist you in conducting this comprehensive evaluation.

C. 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 the violations. Please include an explanation of each step being taken to prevent the recurrence of the 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.

Your written notification should refer to the Warning Letter referencing CMS #547494.
Please submit your written response to:

John W. Diehl
Director, Compliance Branch (DCB)
U.S. Food and Drug Administration
Office of Pharmaceutical Quality Operations (OPQO), Division II
4040 North Central Expressway, Suite 300
Dallas, Texas 75204

You may submit your written response via e-mail to Mr. John Diehl at [email protected]. If you have questions regarding the contents of this letter, please contact John Diehl at 214-253-5288, or Thao Ta, Compliance Officer, at 214-253-5217.

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

cc:
Ricque A. Gonder
Branch Manager
Park Infusioncare LP
dba Preferred Homecare
13621 Inwood Road, Suite 420
Dallas, Texas 75244-4645

Mr. Michael Zuga
Senior Vice President
Preferred Homecare (Corporate Office)
4601 East Hilton Ave., Suite 100
Phoenix, Arizona 85034