For this week’s guidance Dr. D decided to change it up a bit and write about FDA’s “Most Wanted List.” Consider this week’s guidance the doctor’s version of America’s Most Wanted. It is the doctor’s opinion that the criminals placed on the FDA’s Most Wanted List are just as evil as some of the fugitives being sought by the FBI and placed onto the FBI’s “Ten Most Wanted List.” For those readers not familiar with the FDA’s version of seeking the public’s help in bringing bad apples to justice, the list contains the names of individuals that have violated the Federal Food, Drug, and Cosmetic Act, resulting in the death or serious injury of patients in exchange for making money, and lots of it. You can find the list on the FDA’s Office of Criminal Investigations’ page. On the top of the list, is a gentleman by the name of Dushyant Mahendrabhai Patel. If you know Mr. Patel, please contact the local authorities, after reading this week’s Devine Guidance, of course. Between 2003 and 2008, Patel was the president of AM2PAT, Inc. The primary product for AM2PAT was the manufacture of syringes filled with heparin and saline. During Patel’s tenure at AM2PAT, his company began shipping contaminated syringes resulting in serious patient injury some patient deaths. The action taken by FDA was swift and in June 2005, an agency investigator appeared in the lobby of AM2PAT’s Raleigh, North Carolina facility for a cup of coffee and an inspection. Please keep in mind, the agency has no problem with foisting (look-it-up) their beliefs upon medical device companies that fail to comply with the quality system regulation. Enjoy.
Warning Letter – August 2005
As previously mentioned, the FDA showed up on the doorstep of AM2PAT for the purpose of performing an inspection. In June 2005, an investigator spent 15-days at the AM2PAT facility and the results of the inspection were not pretty. The observations included:
- Failure to validate critical processes – §820.75(a);
- Failure to establish sufficient environmental controls – §820.70(c);
- Failure to establish procedures for device acceptance – §820.80(d);
- Failure to establish procedures for receiving inspection – §820.80(b);
- Failure to establish complaint handling procedures – §820.198(a);
- Failure to establish procedures for quality audits – §820.22;
- Failure to establish effective document control procedures – §820.40;
- Failure to establish and adequate training program – §820.25; and
- Failure to provide sufficient personnel with the appropriate level of education – §820.25.
Additionally, the warning letter identified that some of the responses to the Form 483 observations were not adequate. Merge nine Form 483 observations with a deficient response and the end result is a warning letter. What a surprise? Unfortunately my dear readers, this story does not end after the warning letter.
Department of Justice Involvement
It appeared that once the complaints relating to patients developing bacterial infections after being injected with syringes manufactured by AM2PAT (spinal meningitis and permanent brain damage) and subsequent patient deaths occurring, some rocket scientist figured out that there just might be a problem with product quality. In fact, AM2PAT was knowingly entering contaminated products (entering into interstate commerce) and falsifying the sterility records. Upon completion of the joint OCI and DOJ investigation, AM2PAT’s quality control director, Ravinder Kumar Sharma and Aniruddha Patel, the company’s plant manager, were indicted for:
- Making false statements to FDA
- Falsification of product sterilization records (product was not properly sterilized and tested prior to shipment)
- Knowingly entering misbranded and adulterated product into interstate commerce, with the intent to defraud.
Sharma and Patel pleaded guilty to the charges in April 2008 and each were sentenced to a 54-month, all-inclusive vacation in federal prison. However, like a rat scurrying in the dark of night, Dushyant Mahendrabhai Patel managed to disappear and escape justice. In April 2008, AM2PAT and Patel were indicted on charges of: (a) conspiracy; (b) mail fraud; (c) making false statements to FDA; and (d) the distribution of medical devices that were misbranded and adulterated.
Folks, Dr. D will leave the readers with just one takeaway from this week’s guidance. Yes, designing, developing and the entering into commerce of medical devices can be quite profitable. However, profits should never outweigh patient safety. One thing all individuals working in the medical device industry, regardless of position (assembler, inspector, engineer, clinician, sales, or even the Chief Jailable Officer), the devices you enter into commerce may be used to treat a loved one. If you are willing to take shortcuts, please do Dr. D a great big favor and get out of the industry now. Yes, profits are important; however, so is the design, development and introduction into commerce medical devices that are safe and effective in their use. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (April 2014) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- Dushyant Mahendrabhai Patel. (2015). Office of Criminal Investigations (OCI) Most Wanted Fugitives. Accessed July 19, 2015. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/OCIsMostWantedFugitives/ucm389556.htm#bridgmon
- Employees of pre-filled syringe manufacturer sentenced for misbranding the medical devices. (February 2009). United States Department of Justice. Accessed July 19, 2015. Retrieved from http://www.justice.gov/usao/nce/press/2009/2009-Feb-23_2.html
- FDA’s enforcement page. (August 2005). Accessed July 19, 2015. Retrieved from http://www.fda.gov/
- FDA’s FY 2011 congressional budget request. (2010). Accessed July 19, 2015.
- Jewett, C., & Shelton, D. (June 2009). Tainted syringes slipped past FDA’s watch. Chicago Tribune. Accessed July 19, 2015. Retrieved from http://www.propublica.org/article/tainted-syringes-slipped-past-fda-watch-607