Inspections, Compliance, Enforcement, and Criminal Investigations

TriOak Foods Inc 6/5/15

  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

 

June 5, 2015
 
WARNING LETTER
 
CHI-5-15
 
 
 
Delivered UPS Next Day                                         
Signature Required
 
Randy Pflum
President
TriOak Foods Inc.
103 Railroad Street
Oakville, Iowa 52146
 
Dear Mr. Pflum:
 
The Food & Drug Administration (FDA) and the Illinois Department of Agriculture (IDA) conducted an inspection of your licensed medicated feed mill, TriOak Foods, Inc., located at 106 Industrial Park Road, Bushnell, IL, on January 13 through January 15, 2015.  This inspection documented significant deviations from the 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]. Such deviations cause medicated feed manufactured, processed, packed, or held at your facility to be adulterated under Section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). 
 
The investigation found that your firm’s manufacturing processes did not conform to the CGMP requirements for medicated feeds. The deviations observed by the investigators during the inspection include, but are not limited to, the following:
 
1)    Your firm lacks a Master Record File that includes the name of the medicated feed, the name or measure of each drug and non-drug ingredient used in manufacturing, a copy of the label or labeling, manufacturing instructions or reference thereto that have been determined to yield a properly mixed medicated feed of the specified formula for each medicated feed produced, and appropriate control directions including the manner and frequency of collecting the samples for assays as required by 21 CFR 225.102(b)(1). Specifically:
 
When the investigators requested to review documentation of your Master Record File, your firm supplied the investigators with facility standard operating procedures (SOPs). These SOPs lack the information required to be included in the Master Record File and had not been prepared, checked, dated, and signed by a qualified person as required by 21 CFR 225.102(b)(1). Your firm does not maintain a Master Record File that contains manufacturing instructions including, specified formula, mixing steps, mixing times, or sampling procedures. 
 
2)    For feeds requiring a medicated feed mill license for their manufacture and marketing, at least three (3) representative samples of medicated feed containing each drug or drug combination used in the establishment shall be collected and assayed by approved official methods at periodic intervals during the calendar year as required by 21CFR 225.58(b)(1). Your firm failed to perform all the required assays during 2014. Specifically:
 
Your firm manufactured multiple batches of medicated feed containing (b)(4), a Category II Type A Medicated Article, during the calendar year 2014.  However, only two (2) samples were collected for assay results at periodic intervals during the calendar year. 
 
Additionally, your firm manufactured multiple batches of medicated feed containing, (b)(4) a Category II Type A Medicated Article, during the calendar year 2014. However, you collected less than three samples for assay results at periodic intervals during the calendar year. You collected one (1) sample in August 2014, and claim in an affidavit that you collected a second sample, but analysis results had not been returned from the lab at the time of inspection.
 
Furthermore, your firm manufactured multiple batches of medicated feeds containing (b)(4), a Category II Type A Medicated Article, during the calendar year 2014. However, you collected less than three samples for assay results at periodic intervals during the calendar year. You collected one (1) sample in April 2014, and claim in an affidavit that you collected a second sample, but analysis results had not been returned from the lab at the time of inspection.
 
3)    Your firm failed to implement an investigation and corrective actions when assay results show medicated feed not in accord with label specifications and not within permissible assay limits as required by 21 CFR 225.58(d).   Specifically:
 
Our inspection found that your firm failed to investigate and implement corrective action when an assay for (b)(4) was out-of-limits. On August 4, 2014 your firm manufactured a medicated feed using (b)(4), a Category II Type A medicated article. On August 13, 2014, analysis of a sample you submitted for assay confirmed the feed was significantly subpotent resulting in only (b)(4) while the level guarantee was (b)(4).  Without investigating the out-of-limits assay result or implementing corrective actions, including establishing proper control procedures, your firm continued to manufacture and distribute medicated feed with (b)(4) on three separate occasions from October 30, 2014 through January 15, 2015.  A representative of your firm stated in an affidavit that your firm does not have written procedures for follow-up of out-of-limit assays. 
 
4)    Your firm’s production records were not endorsed by a responsible individual in the form of a signature or initials as required by 21 CFR 225.102(b)(2)(i). In addition, your firm’s batch production records were not checked by a responsible individual at the end of each working day in which a product was manufactured to determine whether all required production steps were performed as required by 21 CFR 225.102(b)(4). Specifically:
 
Our inspection found Batching Run Reports from January 9, 2015, which were not checked by a responsible individual and endorsed by either a signature or initials. Further, the Daily Product Summary sheet from January 9,2015 shows the end of the working day productions which have not been checked by a responsible individual to determine if all productions steps have been performed.
 
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 CGMP violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these CGMP 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) [21 U.S.C. 360b(a)(2)] of the Act and 21 CFR 515.22(c)(2).
 
This letter constitutes official notification under the law. Based on the results of the January 13 through January 15, 2015 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, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
 
You should notify this office, in writing, within fifteen (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 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.
 
Please send your reply to the Food and Drug Administration, Attention: Nicholas F. Lyons, Director of Compliance, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 451425) when replying. If you have questions about the content of this letter, you may contact Mr. Lyons at (312) 596-4220 or e-mail Nicholas.Lyons@fda.hhs.gov.
 
Sincerely,
/S/
Sandra K. Sylvester
Acting District Director

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