New Delhi, Dec 31, 2014: Recently on 19 December 2014, The Silvasa facility of IPCA Laboratories received Form 483 having 5 observations by US FDA. However according to the documents of USFDA this is not the first time the company has received form 483.Previously the facility had received Form 483 in the July 2012 having 10 observations and an Establishment Inspection Report in January 2014 which cited that the facility has significant problems and also recommended for issuance of warning letter to the facility.
The Silvasa Facility also faced inspection by US FDA in May 2010.The inspection was classified as an “official action indicated (OAI)”.This term is used by USFDA when they find significant objectionable conditions or practices in the system during investigation and regulatory action is required to address the facility’s lack of compliance with regulations.
According to the EIR report of January 2014, the warning letter was recommended for “significant problems in investigations, corrective and preventive actions (CAPA), numerous analyst errors and glassware contamination incidents”. However as per USFDA letter dated 5 April 2013, the responses were reviewed by them which the company gave on 20 August 2012 with supportive documentation on the basis of which the facility was classified as acceptable. The EIR report stating stringent action to be taken against the facility was released in the month of January which is 9 months after the USFDA letter.
The EIR report said that the Drug products were marketed in the US prior to full assessment of the product to assure that the product meets the quality, purity and potency through the shelf life of the product by giving example of three validation batches of a drug which were validated and marketed in the US before establishing the stability of the product. Later on these batches were recalled due to failure of the stability tests.
Other observations were no investigation of the apparent trends in the stability data, no thorough investigations of the tests and laboratory incidents, lack of objective evidence for the root cause of certain problems and no investigation of systematic nature of problems. One of the significant deficiency observed was that the preventive actions were inadequate and not reviewed for the effectiveness of the corrective actions and 11 examples of the same was cited in form 483. Also inadequate laboratory controls were observed in terms of out-of-specification (OOS tests) and laboratory incidents, analyst error and glassware contamination.
Form 483 issued on 19 December 2014 is based on the incomplete data submission and record keeping.IGMPI(http://www.igmpiindia.org/)
