Posted on 08/16/2020 1:28:08 PM PDT by MurrietaMadman
Warning Letter: 320-19-04 Return Receipt Requested
November 29, 2018
Mr. Jun Du
Executive Vice President
Zhejiang Huahai Pharmaceutical Co., Ltd.
Coastal Industrial Zone, Chuannan No. 1 Branch No. 9
Donghai Fifth Avenue, Linhai, Taizhou Zhejiang 317016
CHINA
Dear Mr. Du:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Huahai Pharmaceutical Co., Ltd., located at Coastal Industrial Zone, Chuannan No. 1 Branch No. 9, Donghai Fifth Avenue, Linhai, Taizhou Zhejiang, from July 23 to August 3, 2018.
This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your August 26, 2018, response in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific deviations including, but not limited to, the following...
(Excerpt) Read more at fda.gov ...
I did a search on the listed manufacturer SOLCO and Solco is a fully owned subsidiary of Prinston Pharmaceutical, Inc. and Zhejiang Huahai Pharmaceutical, leaders in drug development and manufacturing of Active Pharmaceutical Ingredients (API) and finished dosage products...
The FDA link was pretty close behind.
Yeah, I know almost two years have passed since this warning letter was issued to them but if you click on the link their FDA contact history runs every couple of years. I thought some Freepers might be interested what with the Bat virus and all.
Thank you!
Every medicinal prescription should have country of origin written on it in bold letters.
We should demand it !
Leni
Yeah. It isn't.
It is an 80% of the original which means it may work the same, better, not as well or not at all.
Every time they switch you to a new generic treat it as an entirely new medicine because it is a new medicine.
You may have new side effects or you may not have any.
I did not know that. Thanks for the information. I thought it was nasty enough to conspire against their customers by silence. Now they upped the ante by lying.
We should demand it !
I think your suggestion, if acted on, will save more lives than these masks they're pushing. Great idea, Leni
You’re welcome!
Short version is that any generic only has to be 80% as effective as the name brand. They tell you that it is "the same as" and legally it is. But really it is not. That 20% along with add in and fillers can mess you up.
In my case the first generic they put me on for my migraine worked just fine. The second not only did not work very well but gave me a sour stomach for a couple of day after the migraine.
Keep a record of which generic worked by noting it's manufacturers name. If the one they switch you to does not work as well or it is problematical in any way then you can request they go back to the one that worked. If they so no, and they may, then you can switch to a pharmacy that does carry that manufacturer's product. It is a pain to do but right now it is your only option.
I’ve been told this by several doctors and experienced it myself. I really hate thyroid meds.
Thanks again.
You are welcome.
Differences among generics and between generics and brand name often has to go with absorption characteristics. The actual drug content may be the same.
That is awful. They should know better than to do that.
You just hit on an oft ignored salient point of the high horse men of science who argue their results are measurably supported by experiment. Except when they're not; then the men of science, I've noticed, rely on a mix of bonhomie and bluster.
In this case the use of 'may' in an explanation of cause and effect regarding the performance of different brands of pharmaceuticals does not manifest a strong sense of science.
To be fair, I looked but did not find 'may' in the Scientific Method Vocabulary.
Got a new prescription last week for lisinopril but I went to Rite-Aid this time. Before I paid for it, I asked what the manufacturer name was. Solco was the reply so I cancelled it and went to another neighborhood pharmacy and learned they too only had Solco.
Called the grocery store pharmacy and was told Solco.
Went to Meijers... Solco.
As relations with PRC deteriorate Chinese pharma is everywhere?
UNusual, I thought, what with the impression that the U.S. was pulling back into a made in the USA mode.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.