The manufacture of eye drops at the Chennai-based business has been halted by India’s Central Drugs Standard Control Organization (CDSCO) after the US FDA reportedly connected 55 adverse event instances to contaminated eye drops. Let’s read the latest updates for this news.
US FDA suspends eye product production at Global Pharma site
The Food and Drug Administration in the United States has advised customers not to “buy or use EzriCare Artificial Tears” owing to probable contamination. Global Pharma Private Healthcare Limited, situated in Chennai, manufactures the eye drops.
The FDA has barred the import of eye drops and ordered all health practitioners in the nation to cease selling “contaminated” eye drops.
What is the US FDA?
The United States Food and Drug Administration (FDA), founded in 1906, is the federal agency presently in charge of enforcing the requirements of the Federal Food and Drugs Act.
The Food and Drug Administration (FDA) is one of the world’s oldest organisations committed to consumer protection.
As a result, gaining certification from the US Food and Drug Administration is not only a valuable asset, but also a must for starting the process of extending your business in the United States of America.
Following an examination of the items by an FDA representative, the FDA will deliver Form 483 for FDA Certification of the products.
What is USFDA Certification?
A USFDA Certification is a document that certifies that your product is safe and effective for use.
It also indicates that the items being exported to the United States of America are made in conformity with the FDA Guidelines for Current Goods Manufacturing Practices (CGMP).
All enterprises in India that make food, pharmaceuticals, medical devices, or cosmetics must be certified by the US Food and Drug Administration to export their products in the USA along with having Import Export Code Registration.
You won’t be allowed to sell your product in the United States market until it has been approved by the Food and Drug Administration via US FDA Certification.
You can understand the detailed process at: How to Get US FDA Certificate in India?
Why did the US FDA recalled eye drops?
- Lack of acceptable microbiological testing,
- Formulation concerns (the business manufactures and distributes ophthalmic medications in multi-use bottles, without a suitable preservative),
- and a lack of basic controls for tamper-evident packaging
These are all reasons the FDA implied recalling the eye drops. Furthermore, The reason was infections with drug-resistant bacteria, which caused irreversible visual loss in many persons.
CDSCO starts probe on eye drops manufacturing company
The CDSCO of the Union Health Ministry and the State Drug Controller of Tamil Nadu have launched an investigation into the issue.\
“CDSCO and TN State Drug Controller teams (three people each) are on their way to the manufacturing factory in Chennai.
It’s a contract manufacturing facility that supplies the US market through others. This particular medicine is not offered in India “It was said.
US FDA Certification of Sun Pharma pulled up |E-startup India
If you want any other guidance relating to the US FDA Certification, please feel free to talk to our business advisors at 8881-069-069.
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