Inspections, Compliance, Enforcement, and Criminal Investigations
Poly Packaging Systems, Inc. 7/23/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
July 23, 2009
WARNING LETTER NO. 2009-NOL-13
DELIVERY SIGNATURE REQUESTED
Rodney C. Pennington, President
Poly Packaging Systems, Inc.
504 Waterway Drive
Amory, Mississippi 38821-8207
Dear Mr. Pennington:
During an inspection of your firm, located in Amory, Mississippi on April 15 and 16, 2009,
investigators from the United States Food and Drug Administration (FDA) determined your
firm is the contract manufacturer of a Class II medical device, a non-sterile, fluid collection
system. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21
United State Code (USC) 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 these devices are adulterated within the meaning of Section 501 (h) of
the Act [21 USC 351 (h)], in 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, Part 820 (21 CFR 820). A Form FDA 483, List of
Inspectional Observations (FDA 483), was issued to you at the conclusion of the inspection.
These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive
actions (CAPA) [21 CFR. 820.l00(a)]. There are no procedures for implementing CAPA,
including for example, requirements for adequately receiving and analyzing quality data
to investigate and identify existing and potential causes of nonconforming product, or
other quality problems.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating
complaints by a formally designated unit [21 CFR 820.198(a)]. There are no procedures to receive, document, evaluate, and properly determine the disposition of complaints about the device you manufacture.
3. Failure to establish and maintain procedures to control product which does not conform to
specified requirements [21 CFR. 820.90(a)]. There are no written procedures for the
identification, documentation, evaluation, segregation, and disposition of non-conforming
4. Failure to establish and maintain procedures to ensure the device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate the device is manufactured in accordance with the device master record (DMR) and the requirements (21 CFR.820.184).
There are no procedures to ensure DHRs are maintained, and no DHRs maintained to demonstrate the devices are manufactured in accordance with the DMR (21 CFR 820.184).
5. Failure to establish and maintain an adequate organizational structure to ensure the devices are designed and produced in accordance with the requirements (21 CFR 820.20). Failure to establish quality system procedures and instructions and to have management. with executive responsibility, ensure the quality system procedures and instructions are understood, implemented, and maintained at all levels of the organization [21 CFR. 820.20(b), (e), (a)]. Management with executive responsibility have not ensured the quality system procedures and instructions are established and implemented, and employees are trained on such policies.
6. Failure to establish procedures for identifying training needs and ensure all personnel are
trained to adequately perform their assigned responsibilities and failure to document the
training [21 CFR. 820.25(b)]. There are no procedures for identifying training needs, and
company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are performed correctly.
Our inspection revealed your devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information respecting the device, as required by or under Section 519 of the Act, [21 USC 360i], and 21 CFR. 803 - MDR regulation. Significant deviations include, but are not limited to the following:
Failure to develop, maintain, and implement written MDR procedures [21 CFR. 803.17].
There are no procedures established or implemented by which reportable events can be
reported to FDA and properly investigated.
The devices you manufacture are misbranded under Section 502(0) of the Act, [21 USC
352(0)], the device was manufactured, prepared, propagated, compounded, or processed in an
establishment not duly registered under Section 510 of the Act, [21 USC 360].
You should take prompt action to correct the violations addressed in this letter. Failure to
promptly correct these violations 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 penalties. Federal agencies are advised of the issuance of all warning letters
about devices so they may take this information into account when considering the award of contracts. Premarket approval applications for Class III devices to which the QS 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 violations, or similar violations, 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 Kari L. Batey, Compliance Officer, U.S. Food and Drug
Administration at the above address. If you have any questions about the content of this letter
please contact Ms. Batey at (615) 366-7808.
Finally, you should know this letter is not intended to be an all-inclusive list of the violations
at your facility. It is your responsibility to ensure compliance with applicable laws and
regulations administered by FDA. The specific violations noted in this letter and in the 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 violations, and take prompt actions to correct the violations and to bring your
products into compliance.
H. Tyler Thornburg,
New Orleans District
Enclosure: FDA 483