The investigators observed that fundamental raw data were missing with employees conducting re-tests until the desired result was obtained.
Your firm frequently performs 'unofficial testing' of samples, disregards the results, and reports results from additional tests. For example, during stability testing, your firm tested a batch sample six times and subsequently deleted this data, the USFDA said in the letter.
The USFDA expressed dissatisfaction on the responses submitted by Sun Pharma to the observations noted.
Your response is inadequate in that you did not conduct an adequate investigation into the pervasive practice of deleting files... The response does not identify any impurity standards used in your procedures and does not provide the procedures that your firm was using to conduct the 'trial' and 'unofficial' runs, the USFDA wrote.
The regulator observed that the companys investigation revealed 47 instances of apparent trial injections of samples for which the results were out of specification (OOS), and some of these batches were distributed in the US market.
The investigation failed to adequately examine why your analysts hid or deleted these runs. Your response only explains that your firm chose to retest samples from the implicated lots, but does not address the causes of the original OOS results, or justify the basis of your decision to invalidate the original failing result and accept the passing retest result. Such an investigation is necessary for any OOS event, the USFDA remarked.
The regulator said these examples suggest a general lack of reliability and accuracy of data generated by the companys laboratory, which is a serious CGMP (current good manufacturing practices) deficiency that raises concerns about the integrity of all data generated by your firm.
The USFDA also raised concerns on the companys investigation of destruction of CGMP records an act, which by itself is a serious deficiency that raises concerns about the integrity of all records generated by the company.
Your response is inadequate in that your investigation was primarily limited to the discarded CGMP records cited in the Form FDA-483. The investigation did not include a comprehensive review of all records in the waste area or a thorough review of your firms practice of destroying CGMP records, it said.
The regulator ordered Sun Pharma to address the root cause of its failure to detect and control the manipulation, alteration or premature destruction of CGMP records and describe systemic actions to prevent recurrence.
The USFDA had conducted an inspection of the Mumbai-based companys API and finished drugs manufacturing facility between November 13 and 16, 2013, after which it issued a Form 483 listing issues identified in the manufacturing practices which deviated from regulations.
The regulator acknowledged Sun Pharmas correspondence on steps taken to tackle the issue, with the latest dated March 11.
On March 12, the regulator banned products manufactured in the unit from entering continental US.