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FDA establishment 1000112898, Cookeville, Tennessee, United States. Part of Peter Schiff Enterprises's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 2
Last inspection ended: Dec 31, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.30(j). Design history file The design history file was not established.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been maintained.
21 CFR 830.300(a). Devices subject to device identification GUDID data submission requirements. The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been.
21 CFR 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
Official Action Indicated (OAI)
Apr 13, 2017
Devices · Compliance: Devices
8 cited references
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
21 CFR 820.40(a). Not approved or obsolete document retrieval Documents that were obsolete were observed at a location where they are being used.
21 CFR 820.20(a). Quality policy and objectives The quality policy and quality objectives was/were not established by management with executive responsibility.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.120(b). DHR documentation of label release {see also 820.184} The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
Voluntary Action Indicated (VAI)
Apr 12, 2013
Devices · Compliance: Devices
5 cited references
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
Voluntary Action Indicated (VAI)
Dec 7, 2011
Devices · Compliance: Devices
9 cited references
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.86. Acceptance status The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria.
21 CFR 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a method, process, and procedure have not been established.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
Voluntary Action Indicated (VAI)
Aug 30, 2010
Devices · Compliance: Devices
None posted
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Cookeville, Tennessee, United States. Part of