Although this may not come as a surprise to Dr. D’s readers, have you seen those funky contact lenses that can quickly change one’s eye color or even the general appearance, such as giving someone the look of the “eye-of-the tiger”? Guess what? The FDA actually considers these novelty lenses medical devices, not unlike the prescription lenses that millions of people use on a daily basis in support of improved vision. A quick trip to the FDA’s warning letter page has enlightened the doctor about the dangers of these products. In fact, a company in Hawaii that manufactures these novelty lenses recently received a prized agency warning letter for failing to comply with multiple sections of the quality system regulation, including the releasing of non-sterile product into the U.S. marketplace, without obtaining clearance. As many of the readers already know, Dr. D constantly perseverates (look-it-up) on the need for device manufacturers to comply with the Quality System Regulations enforced by FDA. After all, if it walks like a duck and quacks like a duck, it is probably a duck. The same logic holds true for medical devices. Enjoy.  

Warning Letter – 19 May 2015

Dr. D strongly recommends that the readers follow the link under the reference section, log into the FDA’s warning letter page, and read this entire warning letter. It truly is a stunner. However, for those readers not inclined to do so, the doctor has extracted a few of the salient points made within the warning letter.

Unapproved Device

“The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
 
“The inspection revealed that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law.”

Quality System Regulation

“The inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”

Note: There were seven violations of the QSR noted: (a) §820.100; (b) §820.30(a); (c) §820.75(a); (d) §820.75(a); (e) §820.70(a); (f) §820.50; and (g) § 820.140.

Additional violations noted were as follows.

Medical Device Reporting

“Our inspection also revealed that your firm’s device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting.  Significant violations include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.”

Quality, Purity, Strength

“The inspection revealed that your devices are adulterated within the meaning of section 501(c) of the Act, 21 U.S.C. § 351(c) in that its strength differs from, or its purity, or quality falls below, that which it purports or is represented to possess.”
 
“Specifically, the lenses are labeled as “Sterile”; however you have no assurance of the sterility of the product, and our analysis of samples obtained from your buffers, water, saline, and manufacturing environment found microbial contamination including Pseudomonads putida, Bacillus bacteria, unidentified gram positive, unidentified gram negative bacteria, and mold. In addition, the lenses are labeled as containing 0.9% sodium chloride USP solution, buffered with sodium bicarbonate USP, but you manufacture the lenses with non-USP ingredients.”

Use of Unsafe Colors

“The inspection revealed that these devices are adulterated within the meaning of section 501(a)(4)(A) of the Act, 21 U.S.C. § 351(a)(4)(A) in that the dyes used for the purpose of coloring the contact lenses are unsafe within the meaning of section 721(a) of the Act. Under the Act, the color additive and its use must conform to a listing regulation under Title 21 of the Code of Federal Regulations (CFR) Parts 73 and 74.”
 
“Specifically, you told our Investigator that you obtained the (b)(4) fabric dyes from (b)(4) Art Supply and you do not know if the dyes contain colors that are safe for use in contact lenses.  The manufacturer of the dyes labels and distributes the dyes for use in coloring textiles. Furthermore, our analysis of the following (b)(4) Dye samples found them to be unsafe for use in coloring contact lenses: (b)(4) Green Color Dye, (b)(4) Dye, (b)(4) Red Dye, (b)(4) Dye, (b)(4) Blue Dye, (b)(4) Green Dye, (b)(4) Black Dye, and (b)(4) Violet Dye.”

Registration and Listing

“You are also required to submit annual registration for each establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device under section 510(b)(2) of the Act, 21 U.S.C. § 360(b)(2).”

False and Misleading

“This inspection revealed that these devices are misbranded within the meaning of section 502(a), of the Act (21 U.S.C. § 352(a)), in that its labeling is false or misleading in any particular.  Specifically, the contact lenses are labeled as sterile, however laboratory analysis of environmental samples collected from water holding cooler and other solutions that come in direct contact with the lenses found microbial contamination such as, unidentified mold, Pseudomonas putida, Achromobacter denitrificans, Achromobacter xylosidans, Achromobactrum anthropic, Staphylococcus saprohyticus, Stenotrophomonas maltophilia, Ralstonia pickettii, unidentified Enterobacter spp., unidentified Staphylococcus spp, unidentified Bacillus spp, unidentified Achromobacter, unidentified gram positive rods, unidentified gram positive catalase negative rods, and unidentified gram positive pleiomeorphic coccobacilli. In addition, the contact lenses do not receive a bioburden reduction or sterilization treatment prior to distribution.”

Compliance for Dummies

Folks, this manufacturer is completely out of control. Frankly, the day after this inspection FDA should have called in the U.S. Marshals and asked them to bring plenty of padlocks for the doors. Now being the inquisitive type, Dr. D visited the website of the offending device manufacturer discussed in this week’s Devine Guidance. In their FAQ page, fourth question from the top, this firm clearly states that their special-effects contact lenses have been approved by FDA. I guess that would be a big red flag for FDA, as the agency clearly stated in the warning letter that the specialty contact lenses have not been cleared by FDA; and the establishment (9 mm Special Effects) is not registered with FDA. Wow! Additionally, the doctor does not claim to be some sort of biological wizard; however, when presented with a list of microbial contaminants, with many of the contaminants having names most individuals cannot pronounce; bad things are in the cards for the offending establishment. Remember, Dr. D’s inherent knowledge of microbiology consists of knowing that germs are bad things.

Furthermore, employing fabric dye as a colorant used in the manufacture of contact lenses is clearly not a rocket-science type of decision. It is pretty obvious that this establishment has either been given bad advice, or they have just not bothered to consider one tiny little possibility; their product just might be a medical device (e.g., quack-like-a-duck syndrome).  

Finally, considering the warning letter was issued three-weeks ago, and the offending establishment has done nothing to remove the FDA approved comment from their website, reinforces that not only are they ignorant to the regulatory pain the FDA is about to unleash, failure to quickly resolve the issues could threaten the continued solvency of this entity. As many of the readers are painfully aware, the FDA, with the backing of the federal courts, can actually obtain injunctive powers including the ability to seize inventory from offending establishments. Folks, it is not nice to ignore or anger the FDA. Why? If you have to ask, well (deep subject, Dr. D knows), the FDA will make the life of the offending establishment’s Chief Jailable Officer (CJO) miserable. In fact, if you fail to respond to an agency warning letter within the 15-day window, and the regulatory escalation capabilities of the FDA are quickly realized.

Takeaways

For this week’s guidance the doctor will leave the readers with just one takeaway. Please do not be that one establishment that: (a) fails to register with FDA as an establishment; (b) fails to actually sterilize product they claim to be sterile; (c) use additives (e.g., textile dyes) not recognized by FDA as being safe for medical devices; or (d) not bothering to obtain clearance for a finished medical device. Why? Because at the end of the day, bad things will happen once FDA realizes that potentially unsafe and unapproved devices are being entered into commerce in the United States. 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.

References

Code of Federal Regulation. (2014, 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. (2015, May). FDA.gov Website. Accessed June 08, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448437.htm