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During an inspection in September 2024, the FDA identified serious violations of GMP requirements for the manufacture of active pharmaceutical ingredients (APIs) at an Indian facility. Particular focus was placed on the release of API batches affected by a fire and on deficiencies in the stability program.

In July, the FDA published a warning letter to Exela Pharma Sciences, which, in addition to deficiencies in microbiological tests and inspections such as sterility tests, growth promotion tests and environmental monitoring, also included a whole series of other deficiencies. It was the consequence of an inadequate response to the FDA's previous 483 letter.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an Indian contract testing laboratory. Investigations of out-of-specification (OOS) results lacked adequate scientific rationale, and new test results were used to invalidate prior OOS findings without sufficient justification. Furthermore, FDA investigators discovered torn and discarded original CGMP documents in the facility's waste disposal area, and electronic data had been improperly altered or deleted.

In a recently published Warning Letter, the U.S. Food and Drug Administration (FDA) outlined systemic failures in stability testing, storage practices, material testing, finished product release, and water system control at a facility in Utah. During the inspection, the company voluntarily submitted a written statement indicating that it would discontinue the manufacturing of various drug products.