Inspections, Compliance, Enforcement, and Criminal Investigations

Enclara Pharmacia Inc 3/29/17

 

  

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Philadelphia District
US Customs House, Room 900
200 Chestnut Street
Philadelphia, PA 19106
Telephone: (215) 597-4390
FAX: (215) 597-8212 

 

OVERNIGHT VIA U.P.S.
DELIVERY NOTIFICATION REQUESTED
 
 
WARNING LETTER
17-PHI-09
 
 
March 29, 2017
 
Kimberly A. Hunter
Vice President of Fulfillment Operations
Enclara Pharmacia, Inc.
512 Elmwood Avenue
Sharon Hill, PA 19079-1014
 
Dear Ms. Hunter:
 
From June 1, 2016, to June 6, 2016, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Enclara Pharmacia, Inc., 512 Elmwood Avenue, Sharon Hill, PA 19079-1014. During the inspection, the investigator observed 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 June 6, 2016.  FDA acknowledges receipt of your facility’s response, dated June 17, 2016.  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 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 [21 U.S.C. § 351(a)(2)(A)]. For example, the investigator observed that that your firm did not use sterile wipes and used a non-sterile disinfectant as part of your disinfection program for the aseptic processing areas.  
 
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 dated June 17, 2016, in which you referenced your purported compliance with the United States Pharmacopeia (USP)-National Formulary (NF) General Chapter <797> Pharmaceutical Compounding--Sterile Preparations (USP Chapter <797>).  
 
Regarding the insanitary condition observations in the Form FDA 483, your response is not adequate. You indicated that USP Chapter <797> does not require the use of sterile wipes. In addition, you indicated that USP Chapter <797> does not require disinfectants to be sterile. The use of non-sterile wipes and non-sterile disinfectants increases the potential for contamination to be introduced into the aseptic processing area and are insanitary conditions. For more information on compounding, please see FDA’s website, at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
 
FDA strongly recommends that your management undertake a comprehensive assessment of 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.
 
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 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-PHI-09). Please address your reply to:
 
                                    Richard Cherry
                                    Compliance Officer
                                    US Customs House, Room 900
                                    200 Chestnut Street
                                    Philadelphia, PA 19106                                             
 
If you have questions regarding the contents of this letter, please contact Richard Cherry at (215) 717-3075
 
Sincerely,
/S/ 
Anne E. Johnson
District Director
Philadelphia District

 

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