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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dynamic Surgery, Inc. 10/13/09

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New England District
One Montvale Avenue
Stoneham, Massachusettts 02180
(781) 596-7700
FAX: (781) 596-7896


 

WARNING LETTER


NWE-03-10W


VIA FEDERAL EXPRESS


October 13, 2009


Mr. Dennis R. Sleister
President
Dynamic Surgery,Inc.
11 Knight Street Buildings E-18 and F-23
Warwick, RI 02886


Dear Mr. Sleister: 
 

During an inspection of your firm located in Warwick, RI on September 9 through 17, 2009, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures cautery devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
 

This inspection revealed that these 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received your response dated September 29, 2049 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to perform and document revalidation activities when changes or
process deviations occur in the manufacturing operations, as required by 21
CFR 820.75(c). For example, a packaging change was made for your cautery
probes, LCP-14003 lot 090625, and there was no documentation to demonstrate
that this new package did not affect the sterile integrity of the device. We also
observed that you transferred packaging and manufacturing operations to two
separate contract manufacturers. Your firm did not perform any revalidation
activities to demonstrate that these significant changes compromised the
integrity of the finished device.

We have reviewed your response and have concluded that it is inadequate because
you did not provide any validation documentation for the above mentioned changes.
We would expect to see an approved validation protocol as well as a finished report
which includes data and test results, when completed.
 

2. Failure to ensure that when the results of a process cannot be fully verified by
subsequent inspection and test, that the process shall be validated with a high
degree of assurance and approved according to established procedures. The
validation activities and results shall be documented, as required by 21 CFR
820.75(a). For example, during the inspection we observed documents that
demonstrated your cautery probes, LCP-14001 lot 071140, received more than
one sterilization cycle. We did not observe any documentation of post
sterilization testing or packaging integrity testing to show that this resterilization
process did not adversely affect the finished device.

We have reviewed your response and have concluded that it is inadequate because
you did not provide completed validation documentation.
 

3. Failure to maintain a device history record (DHR) that includes acceptance
records which demonstrate that the device is manufactured in accordance with
the DHR, as required by 21 CFR 820.184(d). For example, the DHR for cautery
probe LCP-14003 lot 090625 demonstrated that the device was packaged in a
different box and was not made in accordance with the DMR. There was no
documentation in your device history record that demonstrates your firm
accepted this change in specification prior to the distribution of this lot. We also
observed at least two DHRs that were unsigned and a number of missing DHRs.

We have reviewed your response and have concluded that it is inadequate. Please
indicate in your response to this Warning Letter, how you plan to prevent this
recurrence.

4. Failure to maintain a device history record (DHR) that includes the quantity
released for distribution, as required by 21 CFR 820.18a(c). For example, for 4
of 5 DHRs reviewed, we observed discrepancies in the quantities shipped,
quantities on-hand and quantities sterilized.

We have reviewed your response and have concluded that it is inadequate, since you
have not provided current DHRs that reflect your proposed corrective actions. Please
note that we will need to verify that adequate accounting records are being kept in
current DHRs during a reinspection.

5. Failure to store devices in a manner to facilitate proper stock rotation and to
assess its condition as appropriate, as required by 2l CFR 820.150(a). For
example, during the inspection we observed finished cautery probes on your
finished goods shelf that were labeled as both "Quarantined- Awaiting Sterility"
and "Sterilized Awaiting Test Results". We also observed that product had
already been distributed from this lot. We also acknowledge that you share
finished good storage space with at least two other companies.

Your response to this observation appears to be adequate. Please note that we will
need to verify your promise of this correction during a reinspection.
 

6. Failure to establish and maintain procedures for verifying or validating the
corrective and preventive action, to ensure that such action is effective and does
not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, CAPA #1001 which involved breakthrough problems with the
black insulation on cautery probes, did not include any verification that the new
replacement insulation was effective. Also, CAPA #1002 which involved using
product "as is" (without IFU's and plastic covers), did not include any
verification that the next lot was reviewed as noted in the CAPA.

 

We have reviewed your response and have concluded that it appears to be inadequate
since you did not supply any response to this particular deficiency.
 

7. Failure to maintain device master records (DMRs) that include or refer to the
location of device specifications, including appropriate drawings, composition,
component specifications, as required by 21 CFR 820.181(a). For example, your
firm does not maintain any specifications for the packaging of your finished
device, nor does it include or refer to the Instructions' For Use (IFU).

Your response to this observation appears to be adequate. Please note that we will
need to verify your promise of this correction during a reinspection.
 

8. Failure to establish and maintain procedures for identifying valid statistical
techniques required for establishing, controlling and verifying the acceptability
of process capability and product characteristics, as required by 21 CFR
820.250(a). For example, your firm did not have a valid sampling SOP. We also
observed at least three lots in which the samples pulled did not equal the actual
number of samples required for testing.

We have reviewed your response and have concluded that it appears to be inadequate
since you have not provided documentation to demonstrate that you are currently
following the correct sampling size as described in your SOP.
 

You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
 

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.
 

Your response should be sent to: Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Karen Archdeacon at (781) 596-7707.
 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.

 

Sincerely yours,

/S/

John R. Marzilli
District Director
New England District