US FDA flags ‘significant violations’ of CGMP norms at Gujarat-based Intas Pharma

The US federal health agency Food and Drug Administration (USFDA) has issued a warning letter to Gujarat-based Intas Pharmaceuticals for "significant violations" in following current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

The US FDA inspected the drug manufacturing facility of Intas Pharmaceuticals in Sanand, Gujarat, from November 22 to December 02, 2022. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)," says the letter.

The FDA says during its inspection, the investigators observed "specific violations". It says the company's quality control unit failed to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity.

The company also "failed to ensure the reliability of data relating to the quality of medicines produced" at the facility. "Our inspection revealed serious deviations, including but not limited to, inadequate oversight of original CGMP documents, deficient controls over computerized systems, insufficient laboratory investigations, and aborted chromatographic sequences."

Also, senior facility managers, says FDA, "failed" to exercise their authority and responsibility to ensure reliable data, leading to severe data integrity deficiencies in at production and laboratory departments of the company. "These findings also indicate that your quality assurance function is not exercising its responsibilities, including but not limited to, oversight and control over the adequacy and reliability of CGMP data used throughout your operation," observes the top US health agency.

The FDA report says its investigators also observed "plastic bags filled with torn and discarded original CGMP documents" at the quality control (QC) scrap area under a stairwell, in general, parenteral scrap room, and on a truck outside facility at the company. "Among these, CGMP documents were engineering checklists associated with the environmental monitoring system (EMS), torn Karl Fischer (KF) analytical test reports, auto titration curves, and analytical balance weight slips for finished drug products."

The FDA says an analyst even "destroyed CGMP records" by pouring acetic acid in a trash bin containing analytical balance slips and destroyed KF titration curves and balance printouts.

The agency says the company is responsible for "investigating and determining" the causes of any violations and for preventing their recurrence or the occurrence of other violations. The FDA has also asked the company to "correct any violations promptly", failing which the FDA may withhold approval of new applications or supplements listing at the firm as a drug manufacturer until any violations are completely addressed.

Intas is an Ahmedabad-based vertically integrated pharmaceutical formulation development, manufacturing, and marketing company. It has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. The company is currently present in over 85 countries worldwide, with infrastructure in markets like North America, Europe, Central & Latin America, Asia-Pacific as well as CIS and MENA countries.