Monday 14 June 2021

U.S. FDA Warns Vention Medical on Costa Rica Plant

COSTA RICA BUSINESS NEWS – The U S Food and Drug Administration (FDA) last month slapped Vention Medical with a warning letter over conditions at a plant in Costa Rica, flagging problems with the medical device company’s procedures there.

ventonThe July 1 letter was prompted by an FDA inspection in March of a plant in Barreal de Heredia, Costa Rica, the FDA said.

Vention Medical makes thermotherapy systems, cord blood processing systems, negative-pressure wound therapy equipment and catheters at the plant, according to the watchdog agency.

- Advertisement -

The FDA inspection found that Vention, the result of a rollup of TDC Medical, Advanced Polymers and The MedTech Group, failed to have a validation system in place for its cleaning & sanitation procedures and failed to institute environmental control procedures, according to the letter.

Vention also failed to adequately document its cleaning & maintenance schedules and its corrective & preventive action processes, the FDA said.

Following the 2011 rollup, Vention Medical grew via acquisition with the buyouts of AnsaMed, RiverTech Medical, and Fast Forward Medical. Vention, which is owned by KRG Capital Partners, raised $2.5 million in an equity offering last year.

Source: Massdevice.com

- Advertisement -

- Advertisement -

FACT CHECK:
We strive for accuracy in its reports. But if you see something that doesn’t look right, send us an email. The Q reviews and updates its content regularly to ensure it’s accuracy.

Ricohttp://www.theqmedia.com
"Rico" is the crazy mind behind the Q media websites, a series of online magazines where everything is Q! In these times of new normal, stay at home. Stay safe. Stay healthy.

Related Articles

Diseases, weather and low prices hit the orange sector in Costa Rica

HQ - The appearance of pests and diseases, in particular the...

Central America is back in the news for the wrong reasons, Costa Rica is once again the exception

QCOSTARICA - Osta Rica has been the epicenter of regional diplomacy...

MOST READ

Tilaran, where the wind blows

QCOSTARICA - For years, Tilarán has seen the transit of tourists heading towards Lake Arenal, the homonymous volcano and La Fortuna or towards Monteverde. At...

Southwest adds yet another route to Liberia, now from Denver

QCOSTARICA - Southwest airlines will add a new route to the Daniel Oduber International Airport, in Liberia, this time connecting with the city of...

Simple to request certification of vaccines against covid-19 applied in Costa Rica and abroad

QCOSTARICA - The Ministry of Health issued a new guideline on Thursday that establishes the requirements to request the vaccination certificate against covid-19 in...

The U.S. and Democracy in Nicaragua

Q REPORTS (Council on Foreign Affairs) Democracy is being destroyed in Nicaragua. This has been the long-term project of Daniel Ortega, the country’s dictator,...

Carlos Alvarado describes calls reprehensible the persecution of Ortega against opponents in Nicaragua

QCOSTARICA - The President of Costa Rica, Carlos Alvarado, described the persecution of Nicaragua President Daniel Ortega against opponents as reprehensible after the government...

Your cell phone can now notify you if you had contact with a positive case of covid-19

QCOSTARICA - Fifteen months after the national emergency against covid-19 was declared, Costa Ricans will have a digital platform where you can be notified...

eHow to Become Successful in Online Casino Betting 

To become a successful gambler in the online industry, there is a lot to cover. It can be known to be a vastly different...

Today’s Vehicle Restriction: June 11, “EVENS”

Today, Friday, June 11, only EVENS can circulate. The measure is countrywide and applied between 5:00 am and 9:00 pm, save for those under the...

Today’s Vehicle Restriction: June 8, “ODDS”

Today, Tuesday, June 8, only ODDS can circulate. The measure is countrywide and applied between 5:00 am and 9:00 pm, save for those under the...

WANT TO STAY UP TO DATE WITH THE LATEST!

Get our daily newsletter with the latest posts directly in your mailbox. Click on the subscribe and fill out the form. It's that simple!

Log In

Forgot password?

Forgot password?

Enter your account data and we will send you a link to reset your password.

Your password reset link appears to be invalid or expired.

Log in

Privacy Policy

Add to Collection

No Collections

Here you'll find all collections you've created before.