Summit Nutritionals International response to FDA Warning Letter – 2017
Summit Nutritionals International responds to a letter from the FDA, Food & Drug Administration.
June 8, 2017
U.S. Food and Drug Administration
10 Waterview Blvd.
3rd Floor
Parsippany, New Jersey 07054
Re: Warning Letter, CMS#521980
Dear Sir or Madam :
We are in receipt of the Warning Letter, CMS# 521980 dated May 31, 2017, pertaining to various Inspections that have taken place at Summit Nutritionals International, Inc. Additionally, we would like to thank you for the Informative Inspections that we have had with your compliance officers and representatives. Through the duration of our inspections, Summit has taken away recommendations and implemented new practices for operating Summit Nutritionals.
As a result of our previous inspections, we are pleased to reply to this letter with positive updates.
Per Page 1 of letter and also Comment #1 on Page 2, be advised that Summit Nutritionals has discontinued to offer/sell any Collagen products, regardless of species. We have removed any information from our website pertaining to Collagen.
Referencing Comment #1 and the BSE documentation, should Summit intend on supplying any material stemming from animal, we will have confirmation that the animal is BSE Free before making its way into commerce. We shall maintain records that demonstrate that any products do not contain prohibited cattle materials [21 CFR 189.5 (c)(l)].
Referencing Compliance Policy Guide (CPG) Sec . 560.200 Country of Origin Labeling, If Summit intends on supplying any collagen to its customers, all measures shall be taken in order to comply with branding the product and its country of origin.
On comment #2, from this point forward we will ensure that not only we represent weight in our standard kilograms, but also in terms of avoirdupois pound and ounce In accordance with 21 CRFR 101.7 (b)(l). An example of the new drum label version is attached hereto.
We thank you for accepting our response .
Caesar DePaço
Summit Nutritionals International response to FDA Warning
2021 Summit Nutritionals International
Read MoreKansas City, Missouri Police Department thanks Summit Nutritionals International ®
The Kansas City, Missouri Police Department thanks Summit Nutritionals International ® for their generous donation to purchase equipment needed for their K9 unit.
2017 Summit Nutritionals International
City of DeLand Police Department thanks Dr. Caesar DePaço
The City of DeLand Police Department thanks Dr. Caesar DePaço of Summit Nutritionals International ® for his generous offer to purchase their second Police K-9.
2017 Summit Nutritionals International
Read MorePolice Chief Jason Umberger to Dr. Caesar DePaço
Presentation by Police Chief Jason Umberger to Dr. Caesar DePaço of Summit Nutritionals International ® for donating a Kevlar vest to K-9 Daro and for donating funding for two K-9s!
2017 Summit Nutritionals International
Read MoreFlagler County Sheriff’s Office Thanks Summit Nutritionals International ®
The Flagler County Sheriff’s Office thanks Summit Nutritionals International ® and Caesar & Deanna DePaço for their generous donation of a Police K9. The donation of the Police K9 will allow K9 Kaos to retire after many years of dedicated service to the Flagler County Sheriff’s Office.
.
2017 Summit Nutritionals International
Read MoreBlack River Falls PD’s New Canine Sniffing Through Town
The Black River Falls police department lost it’s police dog earlier this year under unfortunate circumstances, but a short time later were approached with the offer to be gifted another dog and the necessary training.
Officer Jeremy James took the trip out to meet the new dog and participate in the training, once pooch and person were certified it was time to go to work in Black River Falls.
James named his new companion Mattis and has been working the city streets for the past four months.
Jessie Smith, one of the owners of Jessifanny, was the one who originally put in the application with Summit Nutritionals International based on their mutual partnership to help out the Black River Falls Police Department get a new police dog.
Mattis came from a breeder over in Czechoslovakia that Jessifanny Canine Services, the facility that has helped train James and Mattis, works with and they worked with James to get a dog that matched what they wanted.
“We wanted a social dog that’s able to find drugs. That was our main concern,” James said.
In around two months, James was meeting his new partner and off to training in Iron Ridge, making the turnaround from Kilo brief, but James was excited to be getting a new partner.
“It wasn’t weird to get a new dog, I’ve been around dogs my entire life,” James said.
The training all took place in Iron Ridge with a few other departments who were also getting new canines, and after a month of training it was time to return to Black River Falls and hit the streets.
“I saw a big old bull head and that caught my eye. I didn’t know much about shepherds at the time so he was the first dog I saw,” James said.
He brought along a handful of toys and threw them around for Mattis to chase and chase he did, showing off his drive and ambition to his new partner.
When he originally came over from Czechoslovakia, his name was Allen, but being a former Marine, James chose to change the name in honor of General James “Mad Dog” Mattis.
“Canines are such a valuable asset for both the department and the community,” new Black River Falls police chief Kelly Bakken said.
Bakken has always worked on a department with some canine units and said she was excited that Black River Falls had one and wants to make sure the proper training continues.
In his short time with the department, Mattis has already been making himself known in the community as James has responded to over 50 calls in four months.
Of those 50 calls, there’s been a hit on just about every call, which is good for his success rate, but it also shows how bad the drug problem is in the community.
James said he was a bit worried at first that Mattis alerted on every call it seemed, but running him through some blank cars showed the training was working and Mattis was really finding the drugs.
Mattis was trained as a passive alert dog meaning that when he finds the scent he’s looking for instead of barking or scratching Mattis will instead just sit or lay down.
The biggest benefit for having Mattis is that simply by his presence alone, people will turn in drugs before getting him involved said James.
“I remember three or four years ago when Detective Adam Olson was still working nights I would stop people and ask if they had anything in the car and they’d say no,” James said. “There were indicators that told me something was in the car. I’d call Detective Olson and he’d give them the canine spiel and ask them to hand anything over and they would just hand stuff over to him.”
People are now doing the same thing with James and Mattis as their presence becomes more known in the community.
All the work isn’t necessarily bad though, as it’s what these dogs were bred and trained for. They live to work James said.
Mattis has been trained so far in narcotics detection, tracking and apprehension as well, but most of the work has been in drug sniffs.
That training has lead to a lot more work since more finds lead to more paperwork, but it just means Mattis is working as hard as he should be.
“He is great, he’s definitely showing results,” James said. “You see the program is working.”
The hope is that with continued use of Mattis, the department will be better able to track and get a handle of the drug problem in the county.
“Police dogs are just such incredible tools, you can’t replace them and the work they do,” Bakken said.
It’s hard to measure just what sort of impact a police dog has on the problems in a community, but with so many narcotic dogs in the county and more alert officers, the work itself becomes a bit easier.
The process used to stall when people didn’t allow officers into a car to search for drugs, but with a dog on the force, officers know they will be able to search cars and get drugs off the street.
“Working with other departments they’ll say they had maybe 34 calls all year for the dog, Mattis has been here a few months and we’ve had 50,” James said. “So the numbers show we’re combating the problem.”
Part of that success, James said, is having plenty of officers who aren’t afraid to utilize the resource they have in finding narcotics.
Most of his calls keep him in the Black River Falls area, but James has had a few outside the limits and even a call from Osseo that he was eventually called off of.
“I can help everyone, but then again everyone’s helped me,” James said.
The biggest success of the Black River Falls Police Department K-9 Unit has been the community support said James.
James said the community raised $8,000 to send him to training and on top of that, Tyson’s donates all the food while Country Vet covers medical costs for Mattis.
Mattis has also put in work with the community as well, doing demonstrations in churches and common council meetings to show off all the hard work the pair has been through.
James has been given freedom to go and help whoever needs it when its needed, and moving forward the plan is to continue helping others as he was helped in the past.
2017 Summit Nutritionals International
Read More
