Inspections, Compliance, Enforcement, and Criminal Investigations
PML Microbiologicals, Inc. 16-Mar-06
Department of Health and Human Services
Public Health Service
March 16, 2006
RETURN RECEIPT REQEUSTED
In reply refer to Warning Letter SEA 06-23
Kenneth L. Minton, President/CEO
PML Microbiologicals, Inc.
27120 SW 95th Avenue
P.O. Box 570
Wilsonville, OR 97070
Dear Mr. Minton:
The Food and Drug Administration (FDA) conducted an inspection of your establishment located at 27120 SW 95'h Avenue, Wilsonville, Oregon, on November 7- 10, 14-15, 2005. Our investigator determined that your establishment manufactures, labels, and distributes four devices identified as the M0020, FAS MIC Panel; the M0021 ANA-20 MIC Panel, the M0022 ANA-70 MIC Panel; and the P2125, New York Medium, Modified. The first three devices, the M0020, M0021, and M0022, are intended for use in testing the antimicrobial susceptibility of Anaerobic and Fastidious microorganisms. The fourth device, the P2125, is intended for use in the isolation of pathogenic Neisseria
and mycoplasmas. These products are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our review of information collected during the inspection determined a serious regulatory problem with these devices.
Our investigator determined that you are manufacturing, labeling, and distributing the M0020 FAS MIC Panel, the M0021 ANA-20 MIC Panel, and the M0022 ANA-70 MIC Panel under your own name without clearance of your own premarket notification submission (510(k)), in violation of section 510(k) of the Act and 21 CFR 807.81. Under section 510(k) of the Act, unless exempt, each person who is required to register under section 510 must submit a premarket notification to FDA before marketing a device. In accordance with 21 CFR 801.85, a distributor who places a device into commercial distribution for the first time under his own name is exempt from the requirement of submitting a premarket notification if, among other things, it does not change any other labeling or otherwise affect the device. In an affidavit collected during the inspection, Gary D. Wichlund, Corporate Manager Quality and Regulatory Affairs affirmed that PML Microbiologicals, Inc. manufactures and distributes M0020, M0021, and M0022. He also stated that his firm "places our label on the finished product and also handles any complaints about the products." He also explains that PML makes changes to the products with [redacted] approval. Consequently, you are not exempt from the requirement of submitting a premarket notification before you may market these devices.
Review of the product labeling for your FAS and ANA MIC panels by CDRH also revealed that you have made significant changes to the Formula and Interpretation sections of the package insert. The new performance data in the package inserts was not reviewed by FDA in the original 510(k) submissions by [redacted]. These are significant changes that require the submission and clearance of a new 510(k) by FDA prior to marketing as required by 21 CFR 807.81.
With respect to the P2125, New York Medium, Modified, the documentation you provided is insufficient to show that this device was legally marketed prior to May 28, 1976 and, consequently, a 510(K) submission is required before you may legally market this device. To be considered a preamendment device, you must provide adequate documentation, including chain of custody, establishing that the device was in commercial distribution prior to May 28, 1976. See the web page: http://www.fda.gov/cdrh/comp/preamend.html, which discusses in detail how to document that a device was labeled, promoted, and distributed in interstate commerce for a specific intended use and thus may be considered a preamendment device.
Because you do not have marketing clearance from the FDA, marketing your products is a violation of the law. In legal terms, the products are adulterated under section 501(f)(1)(B), 21 U.S.C. 351(f)(1)(B), and misbranded under section 502(o), 21 U.S.C. 352(o) of the Act. Your products are misbranded under the Act because you did not submit a section 510(k) premarket notification, which is required by 21 U.S.C 360(k), that shows your devices are substantially equivalent to other devices that are legally marketed. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your devices, your products are also adulterated under the Act because the law requires, and you do not have, approved applications for premarket approval that shows your devices are safe and effective.
It has also come to our attention that you may currently be marketing the Brain Heart Infusion Agar with 6 mcg/ml Vancomycin, item no. P1174, which is intended for use "as a screen to detect an organism's resistance to high concentrations of vancomycin for Enterococci and for confirmation with all automated MICs and disk diffusion susceptibility testing for S. aureus." Our records do not show that you obtained approval or marketing clearance before you began offering your product for sale. The kind of information you need to submit in order to obtain approval or clearance is described on FDA's device web site at www.fda.gov/cdrh/devadvice. FDA will evaluate the information you submit and decide whether your product may be legally marketed .
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to all applicable FDA regulations and the Act. You should take prompt action to correct these violations. Failure to correct this violation promptly may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of Warning Letters regarding devices so that they may take this information into account when considering the award of contracts.
You should notify this office within fifteen (15) working days from receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483- 4913.
Charles M. Bfeen