Inspections, Compliance, Enforcement, and Criminal Investigations

Morton Drug Company dba Morton LTC 10/26/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

October 26, 2016
 
 
WARNING LETTER
 
 
UPS via Overnight Delivery                                           
Refer to MIN 17 - 01
 
 
Stephen C. Morton
Chief Executive Officer
Morton Drug Company dba Morton Long Term Care
201 E. Bell Street
Neenah, Wisconsin 54956
 
Dear Mr. Morton:
 
From December 15 - 22, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Morton Drug Company (dba Morton Long Term Care), located at 201 E. Bell Street, Neenah, Wisconsin 54956. 
 
During the inspection the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators observed your firm’s operators did not (b)(4) during the production of drug products intended or expected to be sterile. In addition, your firm did not monitor pressure differentials between what you refer to as the “clean room” and “ante room.” Furthermore, our investigators observed operators cleaning the ISO 5 hood with non-sterile cleaning agents while wearing street clothing, and having uncovered arms, exposed facial skin, neck skin, and hair while under the interior of the ISO 5 hood.  FDA issued a Form FDA-483 to your firm on December 22, 2015. 
 
Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (the Act).
 
A. Violations of the Act
 
FDA investigators 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 your drug products to be adulterated under section 501(a)(2)(A) of the Act, 21 U.S.C. § 351(a)(2)(A). For example, the investigators observed that:
 
1.    Your firm used (b)(4) during aseptic production. 
 
2.    Your firm did not monitor or document the pressure differential results between the ISO 5 (b)(4), what you refer to as the “clean room,” and the ante room. 
 
3.    Your firm used (b)(4) non-sterile disinfectants to clean and sanitize the cleanroom areas.
 
4.    Your firm’s pharmacy technician had hair, arms, face, and neck exposed to (b)(4) while cleaning the ISO 5 hood.
 
B. Corrective Actions
 
We acknowledge your January 12, February 29, March 8, March 22, March 28, and April 18, 2016, responses to the Form FDA-483 inspectional observations. Your proposed corrective actions appear to be adequate based on the supporting documentation provided.  The adequacy of the implementation of your corrective actions will be verified during a future inspection.
 
FDA strongly recommends that your management undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems to ensure the adequacy of your corrective action and prevention of insanitary conditions. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug 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 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 violations, as well as copies of related documentation. If you do not believe that the products discussed above violate the Act, include your reasoning and any supporting information for our consideration. If the corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.  Your written notification should be addressed to Brian D. Garthwaite, Ph.D., Compliance Officer, at the address on the letterhead.
 
If you have questions regarding any issues in this letter, you may contact Dr. Garthwaite at (612) 758-7132.
 
Sincerely,
/S/ 
Michael Dutcher
Director
Minneapolis District

Page Last Updated: 01/31/2017
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