You just cannot make this stuff up. In fact, Dr. D is quite happy that my preference in dental hygiene products are dental brush picks versus dental floss, especially after reading the warning letter selected for this week’s Devine Guidance (DG). Now the doctor has nothing against rodents. In fact, rats are intelligent animals that make great pets. The Dr. D’s wife is an animal rehabber so the Devine household has several rodents as pets (not including the rug rats, a.k.a., grandkids). However, these little furry creatures really have no place in a medical device manufacturing establishment. Did Dr. D mention that dental floss is considered a medical device in the United States? During a 2016 visit for a cup of tea and inspection at a medical device establishment located in the Far East, the FDA investigator(s) noticed that the facility being inspected was being overrun with rodents. Unfortunately, these little critters were not part of the workforce and were not properly litter trained. The end result, not wanting to state the obvious but obliged to do so, was rodent crap all over the place. Considering this establishment was dedicated to teeth whitening products, these little brown pellets of joy were clearly going to be problematic. Now, the doctor attempted to surmise the possibility of providing these little visitors with tiny little brooms to police their own mess. Unfortunately, these fury wannabe workers would not be able to sign their training records. The doctor really does have some sympathy for the Chief Jailable Office (CJO) tasked with interfacing with the investigator(s). As Dr. D is pecking away on the laptop while writing this week’s tale, he is fighting back lachrymose (look-it-up) humor. However, Dr. D believes the CJO on the receiving end of this warning letter was lachrymose driven by the results of the inspection. Enjoy!
Warning Letter – July 19, 2016
The offending establishment identified in this week’s DG compounded its compliance problems with FDA when they decided to provide their response to the agency in Chinese. Regardless of how much influence China may exude on the economy of the United States, the last time I checked, the FDA still demands English be used in all correspondences. Not Mandarin, not Cantonese, but English—and hopefully with some level of competency with the grammar. Furthermore, when foreign establishments run afoul of FDA, they face the real threat of right of refusal for their finished devices at all ports of entry into the United States. There is no doubt the agency had some real concerns over the rodent droppings and the potential impact to finished medical devices, especially dental floss. Smile!
Warning Letter Excerpt
Observation One (1) – “Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e). For example, the buildings used in the manufacturing process were infested by rodents. Fresh excrement was observed on the bags of raw materials and on the windowsills in the (b)(4) room.”
“We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not provide a copy or summary of documentation in English.”
“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 violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.”
21 CFR, Part 820.70(e) – Production & Process Controls
(e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
Compliance for Dummies
One of the expectations of our dear friends from FDA is that device establishments establish (define, document and implement) a procedure for pest control. The purpose of this document is to define the process for keeping unwanted visitors/guests from encroaching upon the manufacturing area. If you wish to add solicitations from unwanted sales calls, you can. However, the fundamental purpose of the document should be to keep manufacturing and associated support areas free from unwanted guests such as our fury friends located in the Chinese facility, insect infestations, and the really-really-really-tiny visitors that are known as germs. Now, since Dr. D is not a microbiologist, the knowledge associated with germs is that they are bad when they come into contact with finish medical devices.
Now granted, depending upon the controls necessary to ensure products remain free from sources of contamination that could influence product quality, safety and efficacy, programs should be tailored toward the type of device being manufactured. For example, if a device is advertised as being “free of pyrogens”, chances are pretty good the devices are being assembled in a Clean Environment Room (CER), which is code for cleanroom. Procedures should be scripted that define controls in accordance with ISO 14644-1 requirements. There are many fine establishments such as Certification and Testing Services (CTS) that are well-trained and capable of performing this type of testing.
Furthermore, procedures should be scripted for janitorial controls and the cleaning of the facility and gowning/personal hygiene. For example, the use of disinfectants and the areas these chemicals are to be applied should be documented. The expectations for all personnel entering into the CER should also be defined within a procedure. All personnel entering the CER such as employees, janitors, testing services and consultants such as Dr. D need to be trained to the gowning procedure and the training documented. Remember, if the training is not documented, in the eyes of the FDA it never happened.
Finally, housekeeping is everything. If a regulator walks into a facility and the facility looks like Dr. D’s garage, bad things are going to happen. The facility should always be free of clutter, and be clean and well-organized. Why? If you must ask, initial impressions are always lasting impressions.
For this week’s guidance, the doctor will leave just one takeaway. Although maybe not considered normal in some circles, it is an acceptable practice to keep rodents as pets. Rats really do make fabulous pets and so do bats. However, having these fury visitors inside a medical device facility? Not so much. Until a time comes when rats, bats and mice can be trained to work on finished medical devices and their training documented, they need to remain at home in cages or their natural environment. However, Dr. D loves the idea of having a squadron of bats flying material shortages from the stockroom to the cleanroom. 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.
- Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. 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.
- FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Beyond Technology Corporation Nanchang. Accessed January 22, 2017. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515336.htm