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Dear Mr. Vasiliauskas:

From March 26, 2018, to April 4, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Vitalab Pharmacy, Inc., dba Vasco Rx, located at 4045 E. Bell Road, Suite 163, Phoenix, AZ 85032.  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 April 4, 2018.  FDA acknowledges that on April 4, 2018, you ceased sterile drug production in your firm’s (b) (4) laminar airflow hood, and on April 24, 2018, you voluntarily recalled all products intended to be sterile that were produced using the (b) (4) laminar airflow hood.  FDA also acknowledges your facility’s response to the Form FDA 483, received on July 31, 2018.  Based on this inspection, it appears that you produced drug products that violate the FDCA.

A. 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 design of your (b) (4) laminar airflow hood is deficient.  The back of the hood had a ledge and a gap between the (b) (4) and the (b) (4); these areas represented difficult to clean surfaces potentially harboring contamination.  In addition, your smoke studies demonstrated that the airflow in this hood was turbulent near the work surface where aseptic operations were performed.

2. Your firm used non-sterile wipes as part of your disinfection program for the aseptic processing areas.

3. Poor aseptic practices were observed, including:

a. A technician had his head in the (b) (4) laminar flow hood during aseptic production.

b. A technician’s gloved hand contacted the inner surface of the container closure during aseptic production.

4. Your media fills were not performed under the most challenging or stressful conditions.  Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

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.

B. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483.  We acknowledge your statement, “Upon receipt of our 483, VASCO immediately discontinued use of the [(b) (4) laminar airflow] hood…,” and your subsequent recall of all products intended to be sterile that were produced using this hood. 

Regarding the insanitary condition observations in the Form FDA 483, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. In response to Observation 1 of the Form FDA 483, you stated that you “obtained quotes from (b) (4) for hoods” to replace the (b) (4) laminar airflow hood.  However, it is unclear if a new hood has been installed because you did not provide updated information such as a copy of the purchase order, model and photo of the new hood, or the installation date. 

2. In response to Observation 2 of the Form FDA 483, you stated that you had changed your practice to use sterile wipes in the ISO 5 areas.  However, you did not provide supporting documentation such as copies of the purchase order of the sterile low lint wipes. Note that the use of non-sterile wipes in ISO 5 and ISO 7 classified areas may introduce microbial contamination.

3. In response to Observation 4 of the Form FDA 483, you stated, “All VASCO aseptic compounding technicians have performed and satisfactorily completed a media fill which simulates/represents the process of compounding (b) (4) .”  However, you did not provide supporting documentation, such as your revised media fill standard operating procedure and most recent media fill report.  

The following corrective actions appear inadequate to address the insanitary conditions noted:

1. In response to Observation 3 of the Form FDA 483, you stated that you had implemented the use of sterile goggles to cover the exposed areas around the eyes and face.  However, your response did not address the poor aseptic practice of your aseptic operators putting their heads inside the ISO 5 areas during aseptic production.  This poor aseptic practice may block or disrupt first air in the ISO 5 area.

2. In response to Observation 5 of the Form FDA 483, you stated that you had implemented the use of (b) (4) forceps and tweezers in large batch aseptic production.  It is unclear if the forceps and tweezers you will use in aseptic processing are sterile.  It is also unclear what your current approach is to vial stoppering for small batch aseptic production.  

For more information on compounding, please see FDA’s website, at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.  

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.

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 if you have taken any specific steps to correct the violations cited in this letter. If you do not believe that the products discussed above violated the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office 15 days prior to resuming production of any sterile drugs in your firm’s (b) (4) laminar airflow hood. 

Your written notification should refer to the Warning Letter Number above (570563). Please address your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild
Irvine, California 92612-2506

If you have questions regarding the contents of this letter, please contact CAPT Matthew Dionne, Compliance Officer via email at [email protected] or by telephone at 303-236-3064.

Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV