Inspections, Compliance, Enforcement, and Criminal Investigations

Northridge Hospital Medical Cent 12/13/16

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
December 13, 2016                                                                                    
WL #9-17
Blair W. Galbreath
Director, Pharmaceutical Services
Dignity Health - Northridge Hospital Medical Center
18300 Roscoe Blvd
Northridge, CA 91325-4105
 
Dear Mr. Galbreath:
 
From February 16, 2016, to March 11, 2016, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Dignity Health - Northridge Hospital Medical Center, located at 18300 Roscoe Blvd, Northridge, CA 91325-4105.
 
During the inspection, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigator observed that your facility is not adequately designed for sterile drug production. Specifically, the ceiling of your cleanroom is not easily cleanable, and gaps were observed between the ceiling and a supply air duct. Moreover, your cleanroom is only separated from the general unclassified area via plastic strip curtains, and your facility lacks pressure gauges to monitor the pressure differential between these two adjacent areas. Your facility does not contain an anteroom, and operators were observed donning gowns in an unclassified area.   Operators wash their hands in a sink within the cleanroom where aseptic production occurs. Our investigator also observed poor aseptic practices, including operators not disinfecting their gloves or materials prior to introducing them into the ISO 5 area from the ISO 7 area. In addition, our investigator noted that your firm did not use sterile wipes as part of your disinfection program for the aseptic processing area. 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. Therefore, your products may be produced in an environment that poses a significant contamination risk.
 
FDA issued a Form FDA 483 to your firm on March 11, 2016. FDA acknowledges your firm’s response to the Form FDA 483 on March 15, 2016.
 
Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
A. Violations of the FDCA
 
Adulterated Drug Products
 
The FDA investigator observed that drug products in your facility that were 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 the drug products to be adulterated under section 501(a)(2)(A) of the FDCA [21 U.S.C. §351(a)(2)(A)]. For example, our investigator observed that your facility is not adequately designed for sterile drug production. Specifically, the ceiling of your cleanroom is not easily cleanable, and gaps were observed between the ceiling and a supply air duct. Moreover, your cleanroom is only separated from the general unclassified area via plastic strip curtains, and your facility lacks pressure gauges to monitor the pressure differential between these two adjacent areas. Your facility does not contain an anteroom, and operators were observed donning gowns in an unclassified area. Operators wash their hands in a sink within the cleanroom where aseptic production occurs. Our investigator also observed poor aseptic practices, including operators not disinfecting their gloves or materials prior to introducing them into the ISO 5 area from the ISO 7 area. In addition, our investigator noted that your firm did not use sterile wipes as part of your disinfection program for the aseptic processing area. 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. Therefore, your products may be produced in an environment that poses a significant contamination risk.
 
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
 
FDA acknowledges your response to the Form FDA 483 inspectional observations, dated March 15, 2016. Although several of your proposed corrective actions appear adequate, others are deficient. For example, your response does not indicate that your firm will use sterile wipes to apply disinfectants to your laminar airflow hoods. The use of non-sterile wipes increases the potential for contamination to be introduced into the aseptic processing area. In addition, your response does not indicate that your firm will perform smoke studies as part of your routine certification. Conducting smoke studies under dynamic conditions helps to ensure that unidirectional airflow is maintained while personnel are working in the ISO 5 area.
 
(b)(4). You have indicated that you estimate this (b)(4) to be completed by (b)(4). However, you have not included any supporting documentation related to this (b)(4), so we are unable to evaluate the adequacy of any associated corrective actions. If your target date is delayed for any reason, please notify us in writing with an explanation for that delay.
 
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess aseptic processing operations. A third party consultant with relevant aseptic processing 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 be addressed to:
 
Kelly Sheppard
Director, Compliance Branch
U.S. Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612                                                                                                                
 
If you have questions regarding any issues in this letter, please contact Ms. Mariza Jafary, Compliance Officer via email at Mariza.Jafary@fda.hhs.gov or by phone at (949) 608-2977.
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
Cc:       Virginia Harold, Executive Officer
California State Board of Pharmacy
1625 N Market Blvd, N219
Sacramento, CA 95834
(Via email)

 

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