Inspections, Compliance, Enforcement, and Criminal Investigations
Peter Schiff Enterprises 7/31/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
July 31, 2013
WARNING LETTER NO. 2013-NOL-14
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Peter Schiff, Owner
Peter Schiff Enterprises
4900 Forrest Hill Drive
Cookeville, Tennessee 38506
Dear Mr. Schiff:
On March 22 to April 12, 2013, investigators with the U.S. Food and Drug Administration (FDA) inspected your facility, located at 4900 Forrest Hill Drive, Cookeville, Tennessee. Investigators found that your firm manufactures AC fibrillators, unclassified devices, and silicone-based electrode pads, Class 2 devices, as defined in Section 201(h)(2) [21 United States Code (USC) 321(h)(2)] of the Federal Food, Drug, and Cosmetic Act (the Act), because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man. During this inspection, investigators documented violations of the Quality System regulation, Title 21, Code of Federal Regulations Part 820 (21 CFR 820). These violations cause your devices to be adulterated as defined in Section 501(h) of the Act [21 USC 351(h)] because the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under Section 520(f)(1) [21 USC 360j(f)(1)] or an applicable condition prescribed by an order under Section 520(f)(2) [21 USC 360j(f)(2)].
On April 12, 2013, a List of Inspectional Observations (FDA 483), was issued to Maria M. Williams, Quality Control and FDA Correspondent at your firm. A copy of this FDA 483 is included for your records. The deviations found include, but are not limited to the following:
1. Failure to establish finished device acceptance procedures [21 C.F.R. § 820.80(d)]. For example, there is no assurance each product batch of finished electrode pad met acceptance criteria prior to being released for distribution. On February 11, 2013, Lot 0613, electrode pads, was shipped, although the production record dated February 8, 2013, for this lot was not audited or signed and dated until February 14, 2013.
2. Failure to establish procedures for Corrective and Preventive Action [21 CFR 820.100(a)]. This violation was observed during FDA’s inspections of your facility in 2010 and 2011 and you have failed to take corrective actions. FDA investigators provided Ms. Williams with contact information for FDA’s Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) and the Small Entity Compliance Guide.
3. Failure to perform quality audits (21 CFR 820.22). This violation was observed during inspections of your facility in 1998, 2003, 2004, 2005, 2010, and 2011 and you have failed to take corrective actions.
4. Failure to adequately establish document control procedures (21 CFR 820.40). This violation was observed during FDA’s 2011 inspection FDA investigators determined there is a procedure for this, but it is not being followed. There is no evidence that documents have been reviewed and approved, and there is no means by which to determine which documents are current.
5. Failure to establish procedures for management review [21 CFR 820.20(c)]. This violation was observed during the 2010 and 2011 FDA inspections. There are no procedures to address how management with executive responsibility will review the suitability and effectiveness of the quality system at defined intervals. There is no documentation to show any management reviews have been performed.
This list is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection and previous inspections may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA. You must promptly initiate permanent corrective and preventive action on your Quality System.
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. Additionally, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice, which may include, but are not limited to seizure, injunction, and/or civil money penalties. This was outlined in Warning Letter 2005-NOL-09, dated January 7, 2005, which is also attached for your records. This letter outlines many of the same deviations as found in your most current inspection.
Based on the number of unresolved deviations encountered during the inspection conducted on March 22 to April 12, 2013, you are requested to come to the FDA New Orleans District Office, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee, to discuss the on-going quality deviations at your firm as soon as possible. To properly address the unresolved deviations, we request you bring the following documents: any document pertaining to any defect with your devices; evidence of any devices not meeting specifications; documentation of any device problems; all complaints and complaint logs; customer lists; documentation of any device malfunctions; and any information and documentation of any adverse events related to your devices. This documentation should include information about adult and pediatric fibrillators and electrode pads with wiring.
Please contact Kari L. Batey, Compliance Officer, at (615) 366-7808 in order to set up a meeting. If you have questions about this letter, please contact Ms. Batey at the number provided.
Patricia K. Schafer
New Orleans District