Inspections, Compliance, Enforcement, and Criminal Investigations

Quality Liquid Feeds, Inc 12/30/14

  

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

 

December 30, 2014
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                 
Refer to MIN 15 – 05
 
 
Jeffrey T. Sawle
Plant Manager
Quality Liquid Feeds, Inc.
321 Cedar Falls Road
Menomonie, Wisconsin 54751
 
Dear Mr. Sawle:
 
An investigator from the Food and Drug Administration (FDA) conducted an inspection of your licensed medicated feed mill, Quality Liquid Feeds, Inc., located at 321 Cedar Falls Road, Menomonie, Wisconsin, on July 24 and 25, 2014.  The investigator documented significant violations of Current Good Manufacturing Practice (CGMP) regulations for licensed medicated feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR 225.10 – 225.115), and documented that your firm limited access to or copying of records and refused to allow photography during the inspection, which constitutes delaying, denying, limiting or refusing to permit inspection within the meaning of section 501(j) of the FD&C Act, 21 U.S.C. § 351(j). These violations cause your medicated feed to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 351(a)(2)(B), and section 501(j) of the FD&C Act, 21 U.S.C. § 351(j), respectively. You can find the FD&C Act and FDA regulations through links on FDA’s web page at http://www.fda.gov.
 
During the inspection your firm limited the investigator’s access to or copying of records and refused to allow the investigator to take photographs determined by the investigator to be necessary to effectively conduct the inspection, causing your medicated feeds to be adulterated under section 501(j) of the FD&C Act, 21 U.S.C. § 351(j), in that the medicated feeds have been manufactured, processed, packed, or held in an establishment and the owner, operator or agent of the establishment has delayed, denied, limited or refused to permit inspection. Examples are as follows:
 
1.    You refused to provide access to records documenting the movement in interstate commerce of Type A medicated articles you received, citing company policy. 
 
2.    You refused to allow the investigator to access your complaint file or review any of the complaints therein, citing company policy.  
 
3.    You refused to allow the investigator to take any photographs of your facility including, but not limited to, photographs of Type A medicated article storage conditions that were observed to be in violation of CGMPs, as discussed further below.
 
Our investigator also observed medicated feed CGMP violations including, but not limited to, the following:
 
1.      Your firm failed to properly identify, store, handle and control drugs in the mixing areas to maintain their integrity and identity as required by 21 CFR 225.42(b)(4).  For example:
 
A.   A pallet of (b)(4)™ Type A medicated article stored in the mixing area was under a bulk tote of liquid vitamin E, which was observed to be leaking onto bags of (b)(4)™ and permeating the paper containers.
 
B.   Sixteen bags of (b)(4)® Type A medicated article stored on the bottom of a pallet were observed to be wet and were damp to the touch, and bags of (b)(4)® and (b)(4)® Type A medicated articles appeared to be stained from water or some other liquid substance.
 
C.   Lot codes and expiration dates were observed to have been removed from open bags of (b)(4)® Type A medicated article, (b)(4)™ Type A medicated article, and (b)(4)® Type A medicated article. The open bags were not rolled up or otherwise protected to prevent foreign material from entering the bags. 
 
D.   A jug of (b)(4)® Type A medicated article, located near mixer 2, was cracked and a piece of the jug was missing from one of the corners, exposing the contents to the environment.
 
E.   A partial bag of (b)(4)® Type A medicated article observed in the bagged ingredient storage area of the mixing room had expired on 01/2014.
 
2.    Your firm failed to maintain accurate daily drug inventory records as required by 21 CFR 225.42(b)(6).  For example:
 
A.   The drug inventory listed (b)(4) full bags and (b)(4) partial bag of (b)(4)®. The investigator counted (b)(4) full bags and (b)(4) partial bags of (b)(4)® in the bagged ingredient storage area. 
 
B.   The drug inventory listed (b)(4) full jugs and (b)(4) partial jug of (b)(4)® in inventory. The investigator counted (b)(4) full jugs and (b)(4) partial jug of (b)(4)® in the storage and mixing room areas; your firm failed to record transfer of (b)(4) jugs of (b)(4)® to one of your other manufacturing locations. 
 
C.   The drug inventory listed (b)(4) full bag and (b)(4) partial bag of (b)(4)® in inventory. The investigator observed (b)(4) partial bag of (b)(4)® and the full bag could not be located. 
 
3.    Your firm failed to maintain your building in a reasonably clean and orderly manner as required by 21 CFR 225.20(b)(2). For example:
 
The investigator observed pooled water and spilled liquid product several inches deep on the floor in the mixing area and also observed water flowing into the bagged ingredient storage area.
 
4.    Your firm failed to maintain your equipment in a reasonably clean and orderly manner as required by 21 CFR 225.30(b)(2). For example:
 
The investigator observed valves, pipes, and other pieces of equipment that were leaking, covered with adhesive tape, and spewing steam.
 
These failures to comply with the requirements of the CGMP regulations cause medicated feeds being manufactured at this facility to be adulterated under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, current Good Manufacturing Practice.
 
Finally, the investigator documented that you were unable to locate a copy of your approved medicated feed mill license at the time of the inspection.  Please note that under 21 CFR 510.305(a) you are required to maintain a copy of the approved medicated feed mill license (Form FDA 3448) on the premises of your manufacturing establishment. 
 
The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non‑medicated feeds, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
 
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your medicated feed mill license under section 512(m)(4)(B)(ii) of the FD&C Act, 21 U.S.C. § 360b(m)(4)(B)(ii), and 21 CFR 515.22(c)(2).  
 
Based on the results of the July 24 and 25, 2014, inspection, evaluated together with the evidence before FDA when the medicated feed mill license was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, packing, and holding of medicated feeds are inadequate to assure and to preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter constitutes official notice under the law and provides you an opportunity to correct the above deficiencies.
 
You should notify this office, in writing, within 15 working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the CGMP and other noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District

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