Indoco Receives FDA Warning Letter for Sterile Injectables Plant
Indoco Remedies, a Mumbai, India-headquartered active pharmaceutical ingredient (API) and finished dosage form manufacturer, has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the company’s sterile injectable drug manufacturing facility in Goa, India. The violations were noted during a FDA inspection of the Goa facility from August 31, 2016 to September 4, 2016, and the agency has reviewed Indoco’s September 20, 2016 response and has acknowledged receipt of the company’s subsequent correspondence.
The FDA observed specific violations including, but not limited to, failure to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product and failure to ensure that responsibilities and procedures applicable to the firm’s quality control unit were followed. The FDA noted that from January 2012 to August 2016, Indoco received approximately 1,500 consumer complaints related to leaking, empty, and under-filled sterile solution bottles. An investigation by Indoco indicated that this was a persistent critical quality defect due to a defective filling machine, but the FDA noted that there is uncertainty as to whether the company’s latest corrective and preventative action plan (CAPA) sufficiently addresses the root causes of the recurring defect. Concerning quality control procedures, at the time of inspection the FDA found no evidence that Indoco had sent notification to its customer regarding field reports on the defective product, as stated under the quality agreement with its customers.
In response to the Warning Letter, the FDA requires that Indoco provide risk assessment of all lots of solution currently in the US market within expiry as well as an assessment of other products made in the facility to determine if there are similar defects, an improved CAPA plan, and improvements in the company’s overall handling of complaints and investigation systems. Indoco is also to provide its standard operating procedures for identifying manufacturing and quality issues and for notifying customers of potential field alert report issues as well as related training-program operating procedures that includes identification of all staff who must take the training.
This Warning Letter follows an earlier report that the FDA issued to Indoco after the same inspection period at the Gao facility. The FDA had issued a Form 483 with six observations in September 2016 and had reviewed Indoco’s compliance response under which the agency accepted responses to four of the six observations, according to an Indoco company filing with the Bombay Stock Exchange in March 2017.