The FDA has banned product imports made at a Dr. Reddy's facility in Mexico. The facility, Industrias Quimicas Falcon de Mexico, produces active pharmaceutical ingredients and intermediates. It received an FDA warning letter last month.
The import ban is a "detention without physical examination" of the products, according to an FDA notice, an action sometimes taken by the agency when an inspection reveals GMP violations.
The warning cited four counts, among them manufacturing fundamentals. "Your firm did not validate analytical methods used to test APIs," the letter says, adding "this is just one example of numerous methods used by your firm that had not been validated according to approved procedures." Inspectors found also that cleaning validations were incomplete and some equipment had no documented cleaning validation.