Inspections, Compliance, Enforcement, and Criminal Investigations

Syfrett Feed Co. 7/15/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-18
July 15, 2014
 
Mr. Charles B. Syfrett, I
President/ Owner
Syfrett Feed Company, Inc.
3079 NW 8th Street
Okeechobee, FL 34972-7621 
 
Dear Mr. Syfrett:
 
A comprehensive/directed inspection of your feed manufacturing facility located at 3079 NW 8th Street in Okeechobee, Florida, was conducted by Investigators from the U. S. Food and Drug Administration (FDA) on January 7 – 9, 2014. This was a joint inspection conducted with the Florida Department of Agriculture and the FDA that was directed by the Center for Veterinary Medicine (CVM) in response to your application for a Medicated Feed License. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (The Act) that we found during our inspection of your operation. You can find The Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. This letter pertains only to the deviations found by the Food and Drug Administration Investigators.
 
The inspection documented violations of The Act and its implementing regulations, including significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for unlicensed medicated feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR 225.120 – 225.202). For example, the inspection documented a failure to establish and maintain adequate procedures for the identification and inventory control, including assuring the strength, quality, and purity of your Type A medicated articles and Type B medicated articles, as required by 21 CFR § 225.142. In addition, the inspection documented a failure to ensure buildings and grounds used for the production of medicated feeds are constructed and maintained in such a manner to minimize vermin and pest infestation, as required by 21 CFR § 225.120. Such deviations cause medicated feed manufactured, processed, packed, or held at your facility to be adulterated under section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B). 
 
Further, our investigators established that you were using the new animal drugs chlortetracycline and fenbendazole in combination in cattle feed in your Deseret Range Cubes Med. w/Safeguard product (Batch Run Serial #28031), contrary to the New Animal Drug Application (NADA) approvals for these drugs (see Title 21 Code of Federal Regulations (CFR) § 558.128 and 21 CFR § 558.258 for approved uses of chlortetracycline and fenbendazole, respectively, in cattle feed). Also, our investigators established that the new animal drugs, chlortetracycline, amprolium, and salinomycin were being used in combination in a finished poultry feed in your Syfrett Garcia Chick Grower Med. Product (Batch Run Serial #30352), contrary to the NADA approvals for these drugs (see 21 CFR § 558.128, 21 CFR § 558.55, and 21 CFR § 558.550 for approved uses of chlortetracycline, amprolium, and salinomycin respectively, in poultry feed). The animal feed containing the combination of these drugs in cattle and poultry feeds is unsafe within the meaning of section 512(a)(2)(A)of The Act, [21 U.S.C. § 360b(a)(2)(A)] and adulterated within the meaning of section 501(a)(6) of The Act [21 U.S.C. § 351(a)(6)].
 
In addition, the “Syfrett (b)(4) All Natural Energy Cube,” “Syfrett Deseret Range Cubes Med. W/Safeguard,” and "Syfrett Garcia Chick Grower Med," feeds containing a new animal drug were manufactured at your facility and the associated labeling did not contain the established name of the active drug ingredient of the new animal drug contained in the medicated feed. Therefore, these medicated feeds are misbranded within the meaning of section 502(e)(1)(A)(ii) of The Act [21 U.S.C. § 352(e)(1)(A)(ii)]. In addition, the associated labeling did not include adequate directions for use on the labeling in conformance with the approved application. For example, the “Syffert (b)(4) All Natural Energy Cube” and “Syfrett Deseret Range Cubes Med. W/ Safeguard” labeling did not contain any indications for use regarding the fenbendazole, dose administration instructions for fenbendazole, or feeding limitations for fenbendazole (including a meat withdrawal period for cattle following use of this feed containing fenbendazole). The “Syfrett Garcia Chick Grower Med” labeling did not include any cautionary statement for using amprolium in feeds containing bentonite. Therefore, these medicated feeds are misbranded within the meaning of section 502(f)(1)of The Act [21 U.S.C. § 352(f)(1)].
 
We acknowledge the receipt of your request, dated January 9, 2014 to withdraw your application for a Medicated Feed License. Although this inspection was conducted in relation to your Medicated Feed Mill License Application, during the inspection, our investigators found several deviations from the Current Good Manufacturing Practice (CGMP) regulations applicable to facilities solely manufacturing medicated feeds for which an approved license is not required, 21 CFR parts 225.120 through 225.202.
 
We are also in receipt of your letter responding to the Form FDA 483, Inspectional Observations (FDA 483), signed by Ms. Melissa S. Montes De Oca, Vice President of Syfrett Feed Company, dated January 27, 2014. We acknowledge your firm has made some changes and corrections in response to the observations. However, we have found that, while some individual CGMP deficiencies may have been corrected, your firm has failed to provide sufficient documentation to demonstrate adequate implementation and maintenance of each corrective action to ensure its effectiveness.
 
Additionally, your response did not address your practice of using medicated articles in unapproved combination in your feeds. This violation was explained to you in detail by our investigators during the inspection; yet, you did not affirm your commitment to discontinue this practice and state what procedures you have in place to ensure feeds in unapproved combinations are not manufactured by your firm. 
 
Our evaluation of your written response in relation to each violation is discussed below. The violations observed during the inspection include, but are not limited to, the following:
 
1.    Failure to ensure all deliveries of medicated animal feeds are adequately labeled to assure that the feed can be properly used by the consignee, as required by 21 CFR § 225.180. Specifically, we found a number of medicated feeds whose label did not contain the directions-for-use or other information relative to the medication that is required by the drug approval regulations.   For example:
 
a)    Batch records for batch run serial #30563 of the finished beef cattle feed "Syfrett (b)(4) All Natural Energy Cube", formula (b)(4), indicated that 300 lbs. of “SAFEGUARD MEAL” (Type B medicated feed, fenbendazole flaked meal (b)(4)) was added to this single batch run. On 01/07/14, this product was supplied to your customer with an accompanying label that did not state that the product was medicated and did not state that the feed contained fenbendazole. The label also did not contain any indications for use, dose administration instructions, or feeding limitations (including but not limited to a meat withdrawal period for cattle following use of this feed containing fenbendazole).
 
b)    Batch records for batch run serial #28031 of the finished beef cattle feed “Syfrett Deseret Range Cubes Med. W/Safeguard”, formula (b)(4), indicated that 880 lbs. of “SAFEGUARD MEAL”(Type B medicated feed, fenbendazole flaked meal (b)(4)) was added to this 4 batch run. On 5/31/2013, this product was delivered to your customer with an accompanying label that did not state that the feed contained fenbendazole. The label also did not contain any indications for use regarding the fenbendazole, dose administration instructions for fenbendazole, or feeding limitations for fenbendazole (including a meat withdrawal period for cattle following use of this feed containing fenbendazole).
 
c)    Batch records for batch run serial #30352 of the finished poultry feed "Syfrett Garcia Chick Grower Med", formula (b)(4), indicated that 55 lbs. of "AMPROLIJM (b)(4)" (Type B medicated feed amprolium (b)(4)) was added to this 2 batch run.On 12/19/2013, this product was delivered to your customer with an accompanying label that did not state that the feed contained amprolium and did not include any cautionary statement for using amprolium in feeds containing bentonite.  
 
d)    Batch records for batch run serial #30286 of the finished poultry feed "Syfrett (b)(4) Starter & Grower", formula (b)(4), that was stored on site and sold to unknown cash customers (dates unknown) showed that 242.01 lbs. of "AMPROLIJM (b)(4)" (Type B medicated feed amprolium (b)(4)) was added to this 7 batch run. The label accompanying the product stated that the concentration of amprolium was (b)(4), while the batch records documented that the actual concentration was approximately (b)(4). Six additional batch records were reviewed during the inspection containing amprolium and their corresponding labels also showed that the labeled concentration of amprolium did not match the concentration documented by the formula.
 
The adequacy of your firm’s response cannot be determined at this time. In your response, you stated that all labeling deficiencies were corrected; however, your firm did not include copies of  corrected labels for the products mentioned in this letter for our review. You also did not mention any plans to go back through your formulation/labeling system to make sure there are not other products that contain similar formulation and labeling errors. The implementation of these corrective actions will be evaluated during our next inspection of your firm.
 
2.    Failure to establish and maintain adequate procedures for the identification and inventory control, including assuring the strength, quality, and purity of your Type A medicated articles and Type B medicated articles, as required by 21 CFR § 225.142. For example:
 
The following conditions were observed in the medicated ingredient storage room on 1/7/2014 and 1/8/2014:
 
a)    Non-medicated feed ingredients including iron and enzymes were observed being stored in containers labeled as horse de-wormer (pyrantel tartrate).
 
b)    Partially-used bags of non-medicated feed ingredients were observed being stored exposed and uncovered. An accumulation of dust was observed on the surface of Type A medicated article packages and storage shelves where an open package of MGA 200 (melengestrol acetate, type A medicated article) was also observed being stored exposed and uncovered. The top portion of the opened bag of MGA 200 had been removed and the lot number and expiration date were unable to be identified on this product.
 
c)    Apparent rodent gnaw marks were also observed on four bags of zinc being stored adjacent to medicated ingredients.
 
Your response to this observation is not adequate. You state in your response that your firm corrected all conditions observed for this observation by cleaning the storage room and transitioning all medicated ingredients in your inventory into plastic containers.  To be compliant with this regulation, your firm must demonstrate your new practices for identification, storage, and inventory control of your medicated articles are established and maintained. You did not provide evidence that these procedures have been established and implemented. This could be accomplished by submitting copies of written procedures or training materials, photographs of the new containers and clean facility, as a few examples. 
 
3.    Failure to ensure buildings and grounds used for the production of medicated feeds are constructed and maintained in such a manner to minimize vermin and pest infestation, as required by 21 CFR § 225.120. For example,
 
a)    The investigator observed apparent rodent excrement in your medicated ingredient storage room too numerous to count on the floor, storage shelf surfaces, and on exterior package surfaces of medicated articles.
 
b)    On 1/7/2014, four cats and at least six birds were observed in the warehouse where bagged Type A medicated articles and Type B medicated feeds were being stored.
 
Your response to this observation is not adequate. In your response, although you stated the cats and bird’s nests were removed from your facility and that you would sweep down any reoccurring bird’s nest every other month or as needed, you did not explain  how you plan to  minimize the apparent rodent infestation observed in the  room where medicated ingredients are stored. 
 
The above is not intended as an all-inclusive list of violations. As an animal feed 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 Act and its implementing regulations.
 
The specific violations noted in this letter and in the FDA 483, issued at the close-out of the inspection, may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, take prompt actions to correct the violations and prevent their recurrence, and to bring your products into compliance. Failure to achieve prompt corrective action may result in regulatory action, without further notice, such as seizure and/or injunction.
 
You should notify this office within fifteen (15) business days of receiving this letter of the steps you have taken to achieve and maintain compliance with the law. Your response should include an explanation of each step being taken to correct the violations noted in this letter. If corrective action cannot be completed within 15 business days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
 
Please send your written reply to Erica M. Katherine, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Katherine can be reached at 407-475-4731 or Erica.Katherine@fda.hhs.gov.
 
 
Sincerely,
/S/
Elizabeth W. Ormond
Acting Director, Florida District

Page Last Updated: 08/18/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English