Sun Pharma, a major pharmaceutical company, has been investigated by the health authority in the United States (US FDA Certification) for manufacturing rule violations that occurred at its plant in Gujarat. These transgressions include failing to follow appropriate written procedures designed to prevent the microbiological contamination of drug products.
Sun Pharma gets Warning Letter from US FDA Certification Authority
The United States Food and Drug Administration ( US FDA Certification Authority) issued a warning letter to the Halol factory of Sun Pharma after discovering multiple violations at the facility, which manufactures finished pharmaceutical goods.
Know about US FDA and US FDA Certification
Established in 1906, the United States Food and Drug Administration (FDA) is the federal agency that is now responsible for carrying out the provisions of the Federal Food and Drugs Act. The Food and Drug Administration (FDA) is one of the oldest institutions in the world that is dedicated to protecting consumers. Therefore, obtaining certification from the US Food and Drug Administration is not only an advantageous asset but also a necessary prerequisite for beginning the process of expanding your company in the United States of America.
After the goods have been examined by a representative of the FDA, the FDA will send Form 483 for FDA Certification of the products.
What is a US FDA Registration Certificate?
US FDA Certification or US FDA Registration Certificate is a certificate indicating that your product is safe and effective for usage. It also signifies that the products being exported to the United States of America are manufactured in accordance with the Current Goods Manufacturing Practices (CGMP) that have been established by the FDA Guidelines. In India, all companies that manufacture food, medicines, medical devices, or cosmetics are required to receive certification from the US Food and Drug Administration. If you are unable to obtain US FDA Certification, you will not be permitted to sell your product on the market in the United States.
Understand about it in detail at: How to Get US FDA Certificate in India?
US FDA Warning Letter Details issued to Sun Pharma
The warning letter issued from US FDA mentions that Sun Pharma’s pharmaceutical goods are adulterated because the Current Good Manufacturing Practices (CGMP) are not adhered to in any of the manufacturing, processing, packaging, or holding procedures that you conduct.
Furthermore, the warning letter provides a summary of severe infractions of the standards for finished medicines that are outlined in Current Good Manufacturing Practice (CGMP).
Your company failed to undertake activities within clearly defined zones of suitable size, and it also failed to have separate or defined areas, as well as such additional control measures as were essential to avoid contamination or mix-ups in aseptic processing facilities.
Your ISO 5 cleanroom sections, which are utilized for aseptic compounding and filling, were not planned well and did not provide sufficient protection. In addition to this, the health authority pointed out that the company had not conducted an exhaustive investigation into any inexplicable discrepancy or failure of a batch or any of its components to fulfill any of the standards.
“The significant findings presented in this letter suggest that your company does not operate an effective quality system that is compliant with CGMP,” the letter states.
In the event that infractions are not addressed, the regulator has stated that the Food and Drug Administration (FDA) may refuse to let products made at Sun Pharmaceutical Industries Ltd., Halol, into the United States.
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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