During our June 27 to July 2, 2011 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Yag-Mag Labs Private Limited located at Survey No. 10, Gaddapotharam Village, Jinnaram Mandal, Medak District, Andhra Pradesh 502 319, India, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your API(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
For example, you manufactured approximately [redacted] batches of [redacted], USP, from April 2009 through March 2010, but the batch records were admittedly written months after the batches were manufactured and released for shipment... This finding that manufacturing batch records are untrustworthy represents a basic systemic failure by your company.
...For example, prior to April 2011, you did not use cleaning logs and it was reported to our investigator, by your personnel, that no cleaning was performed. There was no evidence that any cleaning between batches or between product changeovers occurred for non-dedicated equipment.
...For example, [redacted] batches of [redacted] USP were released for distribution from April 2010 through March 2011 without adequate sampling of starting materials. It was observed within the in-house analysis records and through discussion with a firm employee that starting material [redacted], internal lot [redacted] had come from an unknown supplier via a distributor without product label or manufacturer information. According to the in-house records, it was tested by GC, KF and MP, but no raw data could be found to support the testing, nor records of instrument use logs.
...Your response acknowledges that your facility “was not up to the mark of FDA....” and that corrective and preventative actions are needed, but are not completed at this time. We recommend that you conduct a complete and extensive evaluation of your overall quality and manufacturing controls to ensure that all APIs manufactured at your facility meet the quality and purity characteristics they purport to possess. We highly recommend that you hire a third party auditor with experience in detecting data integrity problems, who may assist you in evaluating your serious CGMP deviations.
...Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, until such time as your manufacturing practices are verified to comply with CGMPs, your firm will remain under FDA Import Alert and FDA will continue to refuse admission of all articles manufactured at Yag-Mag Labs Private Limited, India into the United States.So what you're saying is: your records stink, you're not cleaning your equipment and you're not checking your starting material. Annnnd, until you change, you can't sell into the United States.
I'll bet the inspector of these facilities overseas have pretty good stories. And I'll bet that many process chemists around the world get nervous about regulatory agencies knocking on their doors.