Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility.
The FDA handed Intas a five-observation write-up after inspecting the company’s Sanand, India, production plant from Nov. 22 to Dec. 2, 2022. The company got dinged for lapses in quality control, incomplete lab records, testing shortfalls and more.
Chief among Intas’ slights, the company “failed to ensure reliability of data relating to the quality of medicines produced at your facility,” the FDA said in its warning letter. This included “inadequate” oversight of original manufacturing documents, poor control over computer systems and insufficient lab investigations, the agency continued.
The FDA explained that its investigators found plastic bags filled with torn and discarded manufacturing documents in the quality control scrap area under a stairwell and on a truck outside the facility. Among the documents, the FDA discovered engineering checklists, analytical test reports and more.
To make matters worse, FDA staffers caught an Intas analyst destroying manufacturing records “by pouring acetic acid in a trash bin containing analytical balance strips,” the agency said in its report.
Intas faced problems with computerized controls, too. The company’s electronic batch records allowed changes to be made to manual entries prior to saving, the FDA explained, citing one instance in which a production employee was seen manually altering the reported time that an operation was performed.
Meanwhile, this isn’t the first time the FDA has rebuked Intas for using the "douse it in acid" routine. This week’s warning letter follows Intas’ receipt of a Form 483 at the same Sanand plant back in January. In its 11-observation reproof, the FDA laid onto Intas for problems with record-keeping, poorly defined procedures and controls, plus issues pertaining to microbial contamination risk and environmental monitoring.
Notably, the FDA said it uncovered a “cascade of failure” related to lack of oversight on the control and handling of critical production documents.
Intas’ write-up formed part of a series of warning letters the FDA released this week. Other companies caught in the regulator’s crosshairs included Centaur Pharmaceuticals, Baxter Healthcare and over-the-counter drug manufacturer Medgel.
In the case of Centaur—which just recently got slapped with a separate warning letter outlining quality and cleaning lapses at the company’s Maharashtra, India, drug ingredients plant—the FDA issued its warning despite a prior wrist slap in the shape of a Form 483.
The FDA chided Centaur for issues related to cleanliness and sanitization and the failure of its quality unit, according to the letter.
Baxter, for its part, is in hot water over failure to investigate batch discrepancies, poor cleaning procedures and subpar written procedures around production and process control. The company also “failed to use equipment in the manufacture, processing, packing or holding of drug products that is of appropriate design, adequate size, and suitably located,” the FDA said in its report.