Baltimore — On Feb. 24, O&P professionals gathered in Baltimore
for the Food and Drug Administration (FDA) Compliance Seminar hosted by the
American Orthotic and Prosthetic Association (AOPA). The seminar provided
O&P practitioners, manufacturers and distributors the tools and information
to better understand the role the FDA plays in the O&P arena. In the early
afternoon session of the seminar, Larry Pilot, Esq. discussed the proper
ways to prepare for and manage a FDA inspection. Pilot recommended O&P
business owners and managers know the federal acts, read the regulations and
have the confidence to ask questions to inspectors.
Nothing to fall back on
In late October 2010, Brad Mattear, CFo, Midwest sales territory
manager, Cascade Orthopedic Supply Inc., received a phone call from an FDA
inspector informing him that she would be inspecting his facility in the coming
days. Mattear, who was working with a former employer at the time, was
admittedly surprised by the call. He was unaware his central fabrication
facility fell under the FDA’s scope of practice. He had no prior
experience with the FDA and was unsure of his rights or the inspector’s
authority. There was no company policy to fall back on. Despite these
hesitations and the upcoming birth of his first child only days away, Mattear
told the investigator he would be happy to meet with her.
“I was under the impression it was going to be a meet and
greet,” Mattear told O&P Business News.
“Having never gone through this type of investigation, I had no knowledge
or education regarding the FDA. I was under the belief that we had no
affiliation with FDA.”
It is crucial to know what information is subject to FDA control.
O&P managers and business owners like Mattear may not know their rights and
responsibilities or the amount of authority given to FDA representatives during
an inspection of central fabrication or patient care facilities. Education is
the first step when planning for a FDA inspection, and the only way to better
educate your key facility members is to proactively prepare for FDA inspectors.
Mattear received a heads-up phone call from the investigator, but phone calls
are not required by FDA inspectors. Inspectors, with proper credentials, can
inspect your facility unannounced.
Meeting FDA requirements
Before preparing for an inspection, one must first understand the role
the FDA plays in O&P. Sifting through the legalese and superfluous
information can be a daunting task. The Federal Food, Drug & Cosmetic Act
is a good place to start, according to Pilot.
“Read the provisions of the FD&C Act and know the
regulations,” Pilot told the audience at the seminar.
In 1976, Congress passed numerous amendments to the FD&C Act that
extended the power of the FDA to include regulation on all medical devices.
O&P devices are considered medical devices under the broad definition in
the FD&C act. The level of regulation varies according to the
classification of the O&P device — class I, class II or class III.
According to the FDA Compliance Manual, O&P patient care
facilities have been considered exempt from requirements to register as a
medical device manufacturer or to list their devices with the FDA. Still, the
O&P facility may have responsibility to meet FDA requirements on
manufacturers. The definition of O&P manufacturer is muddled, but according
to the FDA Compliance Manual, the FDA has asserted that certain
patient care facilities are considered manufacturers and thus subject to Good
Manufacturing Practice requirements of the Quality System Regulation (21 CFR.
According to the manual, the FDA believes “facilities are moving
away from their ‘core’ function given the evolving nature of O&P
patient care facilities — eg, utilization of central fabrication
A reasonable time
The FDA’s authority is expanding, reaching areas like O&P that
they have rarely tried to investigate before. In terms of FDA inspections,
O&P business owners and manufacturers must focus their attention on
Sections 702, 703 and 704 of the FD&C Act, which give FDA representatives
the authority upon presentation of their credential to conduct investigations.
According to Section 704 of the FD&C Act, the investigator has the
authority “to inspect at reasonable times and within reasonable limits and
in a reasonable manner, such factory, warehouse, establishment or vehicle and
all pertinent equipment, finished and unfinished materials, containers and
What is considered reasonable? According to Pilot, that is entirely up
to you as a business owner.
“I expressed this when I was at the agency and I still do today,
that a good inspector should be in and out of the facility, irrespective of
size, product or personnel in 2 days,” he said. “Sixteen hours.
That’s it. Something wrong with Good Manufacturing Practices (GMPs) can be
spotted easily. Anything over 2 days becomes unreasonable. Tolerate three or
four days. After that, it is mischief.”
Mattear’s inspector visited his facility for 5 days, taking
“copious” notes each day.
“I was going above and beyond to show that we were working with her
not against her,” Mattear said. “I tried not to create a hostile or
contentious environment. That was an error because that is not what we are
advised to do now. Each and every clinical and central fabrication facility
needs to drill this down and how it applies to their business.”
According to Pilot, Mattear actually had the authority to ask the
inspector to come back at a later time.
“Ask them to come back later because this is not a reasonable
time,” he said. “Say ‘I’m sorry, this is inconvenient. It
is not a reasonable time for me because I have patients.’ They’ll
have to go back and then you should get on the phone with AOPA or one of your
attorneys and get some advice from counsel.”
According to Pilot, business owners should appoint one point person
tasked to work alongside the inspector for the entirety of their visit —
whether it be 1 day or 5. The point person is usually the owner or business
manager. One voice controls the flow of information and reduces the possibility
“To be inspected by the FDA requires discipline on the part of the
company prior to inspection,” Pilot told the audience. “Establish a
company policy about what the inspector can do when they appear in the facility
such as when they ask you to disclose documents. There is a requirement to
disclose documents but only documents required by the act or regulation.”
Section 703 of the FD&C Act states: “Upon the request of an
officer or employee duly designated by the Secretary, permit such officer or
employee, at reasonable times, to have access to and to copy all records
showing movement in interstate commerce of any food, drug, device or cosmetic
or the holding thereof during or after such movement, and the quantity,
shipper, and consignee thereof.”
The FDA website has numerous documents that relate to the inspection
process, including the Inspections Operations Manual. The IOM document
contains the instructions an FDA investigator receives prior to visiting a
company and details what they can and cannot ask from a business owner.
Be mindful of the word “refusal.” If the inspector believes
you are refusing to give them documents that they have the authority to obtain,
it will be noted that you refused, which is an actionable offense, according to
section 703 of the FD&C Act.
“Refusal is a buzzword,” Pilot said. “If you get that
kind of reaction from an inspector and you believe you are being forthcoming,
ask [the inspector] why [the document] you are not going to provide is a
refusal. Tell them to put it in writing. Have management look at it and seek
advice from counsel.”
Upon completion of the inspection, the point person has the right to
meet with the inspector whether or not he or she issued written observations
that would be considered “Observations of objectionable conditions.”
When a 483 is issued, the inspector is directed to meet with management.
This provides the opportunity for full discussion of the observations and
possible correction if there were errors. If an inspection goes beyond a day,
it is useful to ask the inspector(s) during inspection and at end of day, if
any ‘objectionable conditions’ have been observed. If necessary and
with knowledgeable counsel, corrections can be made during inspection and
related to inspector at any time.
“When you receive the 483, meet with the inspector and discuss each
and every point,” Pilot said. “If there are marginal or erroneous
observations, discuss correcting or eliminating them at the time. Don’t
miss the opportunity to sit down with them at that time. If you believe
correction is necessary tell them you will do this. Some inspectors are
stubborn. But offer to make the correction before the inspection is finished if
If you are unhappy with the outcome of your inspection, communicate your
dissatisfaction in writing to the district office so your side is on the record
with the FDA.
Mattear attended the seminar, and more than a year after enduring an FDA
inspection, he appreciated the information he learned.
“It makes all the difference in the world having the education and
understanding the FDA’s scope vs. thinking you know what’s
right,” Mattear said. “I know now that she was just doing her job. At
the time, I thought she didn’t belong there. That way of thinking was
incorrect and I know that now. We were only told bits and pieces. We only had
part of the story. That’s where we were. Had we known what was in front of
us, had we known what AOPA presented at the FDA seminar, the outcome would have
been totally different.”
The FDA’s authority on the O&P industry is far from clear and
to some, the seminar may have even created more questions than answers.
“Just tell us what the rules are,” Mattear said. “But
AOPA can not because the FDA can not. Are we assemblers or are we
manufacturers? The FDA needs to come out and make a clear definition of where
we stand. Do something that is a standardized definition, so we can play by the
Mattear advised O&P professionals who may be facing the prospect of
an FDA inspection to make two very important phone calls.
“First and foremost, without hesitation, welcome them to your
facility and be pleasurable,” he said. “Guide them to your waiting
area, but do not leave them unintended. If you are the business manager make
two phone calls: call the owner and the lawyer. I understand and appreciate the
financial impact of calling a lawyer. If you need a prosthetic device, I can
help you. But I don’t know law. You want a buffer between you and the FDA
and that’s your lawyer. That’s your level of protection moving
forward.” — by Anthony Calabro
For more information:
American Orthotic and Prothestic Association. FDA Compliance
Manual: Understanding the FDA for Orthotics and Prosthetics. www.aopanet.org.
Accessed March 5, 2012.
Larry R. Pilot. What To Do When the Investigator Calls? FDA
Compliance Seminar. Baltimore. Feb. 24, 2012.