Trick or Treat! Something frightening just happened to a device establishment located on the East Coast of the United States. An establishment received a prized Agency warning letter, with one of the Form 483 observations cited against §820.70(f) “buildings” or should the doctor say “suitability of buildings”? Seriously, it is Dr. D’s experience that this is a rarely cited observation as most device establishments have a suitable facility to support manufacturing of finished devices. If there are issues with a facility, typically a little bit of tender loving care (TLC) from the facilities manager is all that is required to correct the objectionable conditions. The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation. Maybe FDA is hiring building inspectors for investigators (just kidding). Regardless, no Chief Jailable Officer (CJO) wants to sit across from an investigator from the FDA while the investigator is throwing the suitability of their facility under the bus. These types of facility issues should have been resolved long before the FDA decided to visit for that nice cup of coffee and an inspection. As mentioned earlier, a little bit of TLS would have quickly “palliated” (look-it-up) any pains associated with being on the receiving end of a potential Form 483 Observation. Enjoy!
Warning Letter – 28 September 2017
The establishment’s CJO, on the receiving end of six Form 483 Observations cited in the warning letter mentioned in this week’s guidance, must have been in complete shock when the FDA investigator cited concerns over the suitability of the facility. As mentioned earlier in this week’s Devine Guidance (DG), this is a seldom cited observation that can usually be prevented with a reasonable facility maintenance program. In fact, not unlike the TSA mantra of “If you see something, say something” this concept can easily be applied to a medical device manufacturing facility when it comes to potential lapses in maintenance.
Warning Letter Excerpt
Observation Four (4) “Failure to ensure buildings are of suitable design to perform necessary operations, as required by 21 CFR 820.70(f). For example:
a) Warehouse doors in the shipping and receiving room were observed to be a poor fit for their openings, with gaps wide enough to permit ingress of pests. The shipping and receiving room is adjacent to the (b)(4) performed.
b) Directly above your firm’s (b)(4) area, over an open bin of in-process raw ingredients, insulation materials were observed to be overfilling the wall cavity and coming out of the gap between the wall and the ceiling.”
21 CFR, Part 820.70 – Production & Process Controls
(f) Buildings. “Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.”
Compliance for Dummies
Dr. D would like to put issues associated with facility maintenance into that basket full of low-hanging fruit that can be quickly remediated when facility issues arise. Yes, the doctor realizes that some facility issues can be quite costly to fix. However, the doctor has been involved with remediation activities associated with agency warning letters and these too can become quite costly. It should always be considered a mission-critical activity to resolve any facility issues that can potentially compromise the safety and efficacy of finished medical devices.
Dr. D believes that we can all agree that when a Controlled Environment Room (CER) has issues maintaining positive pressure, relative humidity, or temperature, fixing the CER becomes a high-priority. If a CER has action-level busting particulate counts or excessively-high bacterial colony forming unit (CFU) counts, actions are quickly taken to resolve the issues. So why not exhibit the same sense of urgency when other less-critical areas, within a facility, exhibit some issues?
The doctor believes that establishments should script a facility maintenance program that covers all functional areas, everything from the stock room to the cafeteria. If the doors on the loading dock do not close properly, they need to be fixed. If there is a hole in the roof and rainwater is entering your facility, the hole needs to be plugged. If there is a need to store flammable liquids within a facility, placing flammable materials in the same room as finished devices is probably not a good idea. If the facility handles electrostatic-sensitive materials, then ESD protection is warranted in the manufacturing areas. Folks, it really is nothing more than exhibiting some common sense.
Finally, yes the doctor realizes that many establishments are at the mercy of their landlords when it comes to correcting facility deficiencies. However, at the end of the day, if your establishment’s name is on the product labeling, your establishment owns the responsibility for ensuring the facility is suited for the manufacturing of finished devices.
The doctor will leave the readers with just one takeaway for this week’s guidance. If you see something, say something. It is imperative that all of your team members speak up when they believe questionable conditions exist. As much as most CJOs would like to admit they are in tune with their establishments, Mr. Murphy has a way of rising up in the most inopportune of times. In fact, it is up to all team members of an establishment to protect their CJO’s from being on the receiving end of unwanted and unnecessary Form 483 Observations during an inspection. In closing, thank you again for joining Dr. D; and the doctor hopes 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. (2017, April). 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.
- FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 30, 2017,