USFDA issue notice to Resonance Labs for violations of manufacturing norms
The United States Food and Drug Administration (US FDA) issued a warning letter to Bangalore-based resonance laboratories for filthy manufacturing practices and gave 15 days of time for the company to shape up or ship out.
The warning letter issued by the US drug regulator under various sections of the Food and Cosmetic Act summarized serious omissions and commissions committed by the company at its Doddaballapu facility in the outskirts of the metro. The letter referred to a serious breach of the Current Good Manufacturing Practice (CGMP) regulations applied by the US Food and Drug Administration (FDA). The CGMPs provide systems that ensure adequate design, control and control of manufacturing processes and facilities.
This is the third warning letter issued by the US regulatory body to an Indian bulk drug maker in a short span of two weeks for violating global benchmarks by compromising HACPP (Hazard analysis and critical control points) after an onsite inspection by its investigators.
“This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API 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),” US FDA said.
If the company does not comply with the conditions set out in the warning letter, the drug manufacturer will eventually be marked in red flagged b by the US regulatory authority to export its products to the world's largest pharmaceutical market. The United States is the largest market for Indian manufacturers of generic pharmaceutical ingredients and and branded generic drug producers followed by pre Brexit European Union (EU) and Japan.
In its notice, the FDA said: “We reviewed your May 26, 2016, response in detail and acknowledge receipt of your subsequent correspondence. Your, response was inadequate. Although you committed to addressing issues identified with the water systems and cleaning validation, your overall response lacked details. You also did not include a retrospective review of CGMP deficiencies on the quality of your products already distributed to the United States”.
During the inspection, the US FDA investigator observed specific deviations, including failure to validate that the company's water system is capable of consistently producing suitable water To its intended use; Resonance manufactures APIs that are used by customers to produce sterile pharmaceuticals. It added that the company has not demonstrated that the distilled water used to clean equipment downstream of the purification steps is suitable for use. Also, failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API. It added that the firm uses shared equipment for the API it manufactures. Data from cleaning verification and validation studies found that its cleaning procedures were ineffective.
“Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance”, it said.
Therefore, "the discrepancies cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these discrepancies, determining causes, preventing their recurrence and preventing further violations. Until you correct all deviations completely and we confirm your compliance with CGMP, the FDA may deny approval of any new applications or supplements listing your company as a drug manufacturer. Failure to correct these discrepancies may also result in the FDA refusing the admission of items manufactured to Resonance Laboratories Private Limited. Under the same authority, the articles may be refused admission, in so far as the methods and controls used in their manufacture do not appear to comply with the CGMP, "it added.
The US FDA noted that after the company receives the letter, it must respond in writing within 15 working days. "If you can not complete the corrective actions within 15 working days, please indicate your reasons for delay and your timetable for completion," the letter warned.