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  5. Drug Depot, Inc., dba APS Pharmacy - 501069 - 12/15/2016
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WARNING LETTER

Drug Depot, Inc., dba APS Pharmacy MARCS-CMS 501069 — 15/12/2016

Drug Depot, Inc., dba APS Pharmacy - 501069 - 12/15/2016


Delivery Method:
UPS

Recipient:
Recipient Name
William L. Lagamba
Drug Depot, Inc., dba APS Pharmacy

34911 US Hwy 19 N, Suite 600

Palm Harbor, FL 34684-1921
United States

Issuing Office:
Florida District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Florida District Office
555 Winderley Place, Suite 200
Maitland, Florida 32751 

 
 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-17-02
December 15, 2016
 
William L. Lagamba, Manager
Drug Depot, Inc., dba APS Pharmacy
34911 US Hwy 19 N, Suite 600
Palm Harbor, FL 34684-1921
 
Dear Mr. Lagamba:
 
From December 15, 2015, to January 22, 2016, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Drug Depot, Inc., dba APS Pharmacy, located at 34911 US Hwy 19 N, Suite 600, Palm Harbor, FL 34684-1921. This inspection was conducted after receipt of a MedWatch report dated October 4, 2015, concerning a testosterone drug produced by your firm. 
 
During the inspection, the FDA investigators noted serious deficiencies in your production of sterile drug products, which puts patients at risk. A Form FDA 483, Inspectional Observations, was issued to your firm on January 22, 2016. Based on this inspection, it appears that you have produced drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
 
A. Adulterated Drug Products
 
FDA investigators observed 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, our investigators observed that your firm used non-pharmaceutical grade filters to sterilize injectable drug products. Specifically, the filters were labeled as “not intended for use in direct patient care or diagnostic procedures.” Our investigators noted that partially-stoppered vials were exposed to less than ISO 5 quality air while being (b)(4) In addition, our investigators observed that your firm used non-sterile (b)(4) to wash vials and stoppers prior to sterilization and did not depyrogenate the stoppers used for finished drug products. Our investigators also observed poor aseptic practices, such as an operator transferring items from the ISO 7 cleanroom into the ISO 5 hood without prior disinfection and an operator placing her head, with exposed facial skin, inside the ISO 5 hood while preparing sterile drug products. Our investigators noted that a non-sterile disinfectant was used to clean the ISO 5 hood. Furthermore, your firm failed to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed. 
 
Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, under section 301(k) of the FDCA [21 U.S.C. § 331(k)], it is a prohibited act 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 responses dated February 12, 2016, May 31, 2016 and October 28, 2016 to the Form FDA 483. Regarding our investigators’ observations of insanitary condition described in the Form 483, we are unable to fully evaluate your assertions due to lack of supporting documentation.
 
In response to the partially-stoppered vials that were exposed to the less than ISO 5 quality air during transfer, you stated that you created an ISO 5 working zone within the ISO 7 cleanroom. However, you did not provide supporting documentation for our evaluation, such as the design of the ISO 5 zone, smoke studies reports, and completed media fills for this new process.
 
In response to the use of non-pharmaceutical grade sterilizing filters, you stated that you have performed testing and determined that the filters are safe for human use. However, we cannot fully evaluate this corrective action as you did not provide any supporting documentation, such as your test protocols or acceptance criteria.
 
In response to the failure to perform smoke studies under dynamic conditions, you stated that you would perform smoke studies during your next room certification in May 2016. However, it is not clear if these studies were performed under dynamic conditions and you have not provided supporting documentation for our evaluation.
 
Please be aware that section 501(a)(2)(A) of the FDCA concerning adulteration due to insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.
 
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 and 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 action within 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 Number above (17-02). Please address your reply to:
 
Andrea Norwood, Compliance Officer
Florida District Office
555 Winderley Place, Suite 200
Maitland, FL, 32751
                                                                       
If you have questions regarding any issues in this letter, please contact Ms. Norwood via email at andrea.norwood@fda.hhs.gov or by phone at (407) 475-4724.
 
Sincerely,
/S/
Susan Turcovski
District Director
Florida District