It is not nice to anger Mother Nature, and it is not nice to refuse FDA entry into a device establishment (regardless of location) for the purpose of performing an inspection. In fact, it is downright idiotic to refuse FDA entry into a medical device establishment. Can you say detention without physical examination? Seriously, failure to grant entry for the purpose of an inspection is always going to end badly for a device establishment. However, for a foreign establishment, things usually end up really bad as finish device importation refusal at the port of entry and the risk of detention without examination are real possibilities. Considering the changing tides of the global economy and the emphasis being placed on bringing jobs back to America, a Chinese establishment failing to allow an agency inspection becomes a perilous adventure indeed. In fact, poking a sleeping bear in the eye with a sharp stick might be a viable option for the rocket scientist that said “no” to the FDA. Seriously, “Welcome to China, now go home.” There is no doubt in Dr. D’s deranged mind that the Chief Jailable Officer (CJO) of the offending establishment and the FDA investigator(s) showing up in the lobby for a cup of tea and an inspection are not going to be exchanging a billet-doux (look-it-up) anytime in the foreseeable future. For those of you in the know, an agency warning letter will never be confused with a love letter.  Enjoy!

Warning Letter – July 19, 2016

For this week’s brief guidance, the use of the word “No” has resulted in a whole bunch of trouble for a device establishment in China. The simple Chinese word 沒有 (no), as in “no, you cannot inspect our lovely facility”, has resulted in a prized agency warning letter being issued to the offending establishment mentioned in this week’s guidance. Plus, because our friends from the agency were so thrilled with the cooperation, or should Dr. D say, “lack of cooperation” coming from the CJO of this establishment, the FDA ensured the threat of detention without examination was clearly delineated within the content of the warning letter, ouch!

Warning Letter Excerpt

Observation One (1) – “Failure to allow the completion of an FDA inspection of your facility for the purpose of determining compliance with 21 CFR 820. The refusal to permit an inspection is a violation under 21 CFR 820.1(d).

Given the serious nature of the violations of the Act, devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violation(s) described in this letter.  We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.”

“Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.”

“Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Please provide a translation of documentation not in English to facilitate our review.”

 21 CFR, Part 820.1(d) – Foreign Manufacturers

(d) Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.

Compliance for Dummies

For this week’s guidance the compliance for dummies will be really brief. Comply baby, just comply! Seriously, if a foreign establishment wishes to enter a finished medical device into commerce in the United States, the regulatory sandbox belongs to FDA. Since the FDA owns the regulatory sandbox, all wishing to enter that sandbox shall play by the agency’s rules. It just does not get any simpler to understand. It does not matter if the finished devices are being manufactured in the North Pole in one of Santa’s workshops; Mr. Claus (upon request) must entertain an inspection from FDA. The good news is that since foreign establishment inspections take some planning on the part of FDA, there is always going to be plenty of advance notice as to when an inspection is going to occur. This will allow device establishments with astute CJOs to properly prepare for an inspection.

The FDA’s Office of Regulatory Affairs (ORA) is tasked with managing foreign inspections, including the training of investigators to ensure they have the appropriate skill set to be successful. Additionally, ORA is tasked with coordinating inspections with the Department of State, as the investigations really are considered to some extent a diplomatic event. Remember, although the requirement for foreign establishments to comply with applicable quality, regulatory, and statutory requirements associated with the manufacturing of finished device entered into commerce in the United States, the FDA has no legal jurisdiction over the country-specific laws in the countries visited. Simply stated, FDA investigators are considered guests, albeit very special ones.

When it comes to compliance, the expectation is that foreign establishments comply with the same quality, regulatory, and statutory requirements invoked on United States-based establishments. There is no special dispensation granted; therefore, an establishment refusing FDA entrance in China is going to feel the regulatory pain unleashed by the agency, similar to an American establishment refusing entry. The only difference is that instead of device detention at a port of entry, the FDA may show-up with a cadre of United States Marshalls with chains and padlocks to lockdown an offending facility. Hopefully, everyone gets out before the doors are chained and locked.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. If your establishment designs, develops, and enters into commerce finished medical device, in the United States, hosting an agency inspection is a requirement mandated by law. It makes no sense to refuse an agency request for facility access for the purpose of performing an inspection. The regulatory sandbox belongs to FDA, so to play in their sandbox you must comply with their rules. Even Santa Claus must comply if he is stuffing stockings with finished medical devices. If a CJO decides to say “no”, well, Dr. D has some really sharp sticks and a map to some caves that house some really grumpy bears. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) in the guidance provided. Until the next installment of DG,  cheers from Dr. D., and best wishes for continued professional success.

References

1. Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
5. FDA. (September 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Hubei Hongkang Protective Products Co. Accessed February 12, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm540542.htm