FDA Issues a Warning to Dr Reddy’s Chemicals Unit in Mexico

The US Food and Drug Administration have issued a warning letter to Dr Reddy’s chemicals manufacturing facility, Industrias Quimicas Falcon de Mexico, located in Cuernavaca.

The FDA found some inconsistencies in the manufacturing process at the facility and have mentioned the issues in the letter.

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The FDA statement said, “That inspection resulted in issuance of Form FDA 483, with observations. Dr Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the FDA has asked for additional data and corrective actions to the items listed in the warning letter. Dr Reddy’s takes these matters seriously and will respond to the FDA within the stipulated timeframe.”

The company is putting its best foot forward in resolving the issues.

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