Inspections, Compliance, Enforcement, and Criminal Investigations

Lincare, Inc. 4/25/16

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128

 

April 25, 2016
 
2016-DAL-WL-19
 
WARNING LETTER
UPS Overnight
 
 
Kristen Hoefer, CEO and President
Lincare Holdings, Inc.
19387 US 19 N
Clearwater, Florida 33764
 
 
Dear Ms. Hoefer:
 
From June 1, 2015 to June 12, 2015, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Lincare, Inc., dba United Medical Home Infusion, located at 1527 S. Bowman Road, Suite D, Little Rock, Arkansas 72211-4200. This inspection was conducted in response to information received from the Arkansas State Board of Pharmacy reporting four patients who were hospitalized after receiving Total Parenteral Nutrition (TPN) products produced by your firm at the Little Rock location.
 
During the inspection, the FDA investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators observed five insect-like pests, including a live worm-like pest, in the ISO 8 area adjacent to the clean areas. The investigators also observed two technicians cleaning the ISO 5 hoods wearing non-sterile gloves and touching a liner of a garbage bin and placing their hands back into the ISO 5 areas without sanitizing or changing gloves. Your firm’s aseptic processing area was noted to contain a wooden table and a chair with padding showing deterioration. Wooden tables are difficult to clean and disinfect and may harbor microbial contamination. Furthermore, the investigators found that your firm had failing differential pressures between the ISO 7 area and the ISO 8 Anteroom, which creates the risk of dirtier air mixing with cleaner air within the aseptic processing areas. 
 
FDA issued a Form FDA 483 (FDA 483), Inspectional Observations, to your firm on June 12, 2015. FDA acknowledges your firm recalled all TPNs produced between May 14, 2015 and May 27, 2015. FDA also acknowledges your firm’s response to the FDA 483, dated July 2, 2015. 
 
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 investigators observed that your 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 five insect-like pests, including a live worm-like pest, in the ISO 8 area adjacent to the clean areas. The investigators also observed two technicians cleaning the ISO 5 hoods wearing non-sterile gloves and touching a liner of a garbage bin and placing their hands back into the ISO 5 areas without sanitizing or changing gloves. Your firm’s aseptic processing area was noted to contain a wooden table and a chair with padding showing deterioration. Wooden tables are difficult to clean and disinfect and may harbor microbial contamination. Furthermore, the investigators found that your firm had failing differential pressures between the ISO 7 area and the ISO 8 Ante-room, which creates the risk of dirtier air mixing with cleaner air within the aseptic processing areas.   
 
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 acknowledge your firm’s action taken on May 30, 2015, to cease compounding sterile drug products, and your firm’s action taken on June 9, 2015, to voluntarily recall all sterile drug products within expiry. FDA has been informed that your firm resumed sterile compounding operations on August 28, 2015. We further acknowledge your response to the FDA 483, dated July 2, 2015, and an additional correspondence submitted on your firm’s behalf on January 12, 2016. Although several of your proposed corrective actions appear adequate, others are deficient. For example, in response to our observation of five insect-like pests in the ISO 8 area, you indicated that your pest control contractor will look into the merit of alternate pesticides. However, your firm did not evaluate the adequacy of your current cleaning procedures. Your firm also indicated that you replaced both hoods and the chair that were in use in the ISO 7 Buffer Room 1. However, your firm did not provide any evidence or description of the new equipment that was added to this room.
 
FDA strongly recommends that your firm’s management immediately undertake a comprehensive assessment of your 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 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 are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete the corrective actions within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your firm’s response to this letter should be sent to: Dallas District Office, ATTN: John W. Diehl, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. 
 
If you have any questions about the contents of this letter, please contact John W. Diehl, Compliance Officer, at 214-253-5288.
 
 
Sincerely,
/S/                                                                                                                                 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
CC:
 
James H. Cook, Regional Manager
Lincare, Inc., dba United Medical Home Infusion
1527 S. Bowman Road, Suite D
Little Rock, Arkansas 72211-4200
 
Patricia Newman, Attorney
Lincare Holdings, Inc.
19387 US Highway 19 N.
Clearwater, Florida 33764-3102

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