Transcript Allergan Computerized Systems Validation

Enforcement Basics
Mark Mansour, Jones Day
Elaine Messa, NSF Health Sciences
Marcela Rios Vessell, Integra LifeSciences
Michael Viscido, IKARIA, Inc.
Nancy Singer, Compliance-Alliance, LLC
Question 1
The FDA investigator refuses to provide a daily briefing in a
medical device inspection.
2
Question 2
The FDA investigator states that if you refuse to provide all of
your complaints back to 2003, he will consider this to be an
inspection refusal and note this on the EIR.
3
Question 3
You discover that one of your employees has falsified
information during complaint investigations in order to clear up
the backlog of complaints. You correct the situation. Do you
report this to the FDA, or bring it up during the next inspection?
4
Question 4
You see an employee who has received notice that he will be laid
off in two weeks talking to an investigator.
5
Question 5
During the discussion with management at your facility in New
Jersey, you receive a 483 with a number of significant
observations. The national expert mentions that this year she
had been at your facilities in Florida and Puerto Rico. What
action do you take after the investigator leaves?
6
Question 6
The US marshal arrives at your facility with a warrant of arrest to
seize all finished products.
7
Question 7
Your products are stopped in the LA port of entry. You call the
head of the Import Division in LA and learn that your products
are subject to an import alert. The grounds for the import alert
was an OAI inspection by FDA of your facility in Spain.
8
Question 8
On your most recent inspection, two of the eleven items on the
483 were marked as repeat observations. How do you approach
your response to those observations?
9
Question 9
A man says he is from the FDA and shows a badge, but says that
he left the FDA 482 back at the office.
10
Question 10
You have had two inspections with numerous 483 items on
them. During the recent inspection of your facility many of the
items were repeat observations. You need to brief your
management on the types of enforcement actions FDA can take
against your firm. What do you tell them?
11
Question 11
The FDA investigator asks for a document. You say it will take
four days to get it. The FDA investigator says he believes this is a
circumstance that could fall within the criteria outlined in the
new guidance for delaying a drug inspection. What do you do?
12
Number of 483 Observation
9/30/12 – 9/30/2013
http://www.fda.gov/ICECI/Inspections/ucm381526.htm#devices
Navigation Guides
- www.fda.gov
- Inspections, Compliance, Enforcement, and
Criminal Investigations
- Inspection Observations
483s
Center Name
issued
Foods
2386
Devices
1099
Drugs
690
Veterinary medicine
328
Bioresearch monitoring
273
Biologics
191
Human tissue for transplantation
121
Parts 1240 and 1250
91
Radiological health
32
Sum Product Area 483s from System*
5211
Top 5 Food 483 Citations
Citation
21 CFR
110.35(c)
Number Explanation
318
Long Explanation
Lack of effective
pest exclusion
Effective measures are not being taken to [exclude pests from the
processing areas] [protect against the contamination of food on the
premises by pests]. Specifically, ***
21 CFR
123.11(b)
300
Sanitation
monitoring
You are not monitoring the sanitation conditions and practices with
sufficient frequency to assure conformance with Current Good
Manufacturing Practices including [safety of water that comes into contact
with food or food contact surfaces, including water used to manufacture
ice] [condition and cleanliness of food contact surfaces] [prevention of
cross-contamination from insanitary objects] [maintenance of hand
washing, hand sanitizing, and toilet facilities] [protection of food, food
packaging material, and food contact surfaces from adulteration] [proper
labeling, storage and use of toxic chemicals] [control of employee health
conditions] [exclusion of pests]. Specifically, ***
21 CFR
110.20(b)(7)
224
Screening
Failure to provide adequate screening or other protection against
pests. Specifically, ***
21 CFR
123.6(b)
177
HACCP plan
implementation
You did not implement the [monitoring] [recordkeeping] [verification]
procedures listed in your HACCP plan. Specifically, ***
21 CFR
123.6(c)(1)
171
Food safety
hazards
Your HACCP plan does not list the food safety hazards that are
reasonably likely to occur. Specifically, ***
Top 5 Drug 483 Citations
Citation
Number
Short Description
Long Description
21 CFR
211.22(d)
155
Procedures not in
writing, fully followed
The responsibilities and procedures applicable to the quality control
unit are not [in writing] [fully followed]. Specifically, ***
131
Investigations of
discrepancies, failures
There is a failure to thoroughly review [any unexplained
discrepancy] [the failure of a batch or any of its components to meet
any of its specifications] whether or not the batch has been already
distributed. Specifically, ***
Absence of Written
Procedures
There are no written procedures for production and process controls
designed to assure that the drug products have the identity,
strength, quality, and purity they purport or are represented to
possess. Specifically, ***
99
Scientifically sound
laboratory controls
Laboratory controls do not include the establishment of scientifically
sound and appropriate [specifications] [standards] [sampling plans]
[test procedures] designed to assure that [components] [drug
product containers] [closures] [in-process materials] [labeling] [drug
products] conform to appropriate standards of identity, strength,
quality and purity. Specifically, ***
77
Written procedures not
established/followed
Written procedures are not [established] [followed] for the cleaning
and maintenance of equipment, including utensils, used in the
manufacture, processing, packing or holding of a drug
product. Specifically, ***
21 CFR
211.192
21 CFR
211.100(a)
21 CFR
211.160(b)
21 CFR
211.67(b)
106
Top 5 Device 483 Citations
Citation
Number
Short Description
Long Description
378
Lack of or
inadequate
procedures
Procedures for corrective and preventive action have not been
[adequately] established. Specifically, ***
21 CFR
820.198(a)
245
Lack of or
inadequate
complaint
procedures
Procedures for receiving, reviewing, and evaluating complaints by
a formally designated unit have not been [adequately]
established. Specifically,***
21 CFR
820.100(b)
133
Documentation
Corrective and preventive action activities and/or results have not
been [adequately] documented. Specifically, ***
21 CFR
820.75(a)
127
Lack of or
A process whose results cannot be fully verified by subsequent
inadequate process inspection and test has not been [adequately] validated according
validation
to established procedures. Specifically, ***
21 CFR
803.17
124
Lack of Written
MDR Procedures
21 CFR
820.100(a)
Written MDR procedures have not been [developed] [maintained]
[implemented]. Specifically, ***