Warning Letter: Inadequate employee training (s6660c)

Tags: Medical Device Manufacturer | No Procedure for CAPA | No Procedure for Training
January 24, 2008

Failure to ensure that all employees have the necessary training and experience to perform their jobs, as required by 21 CFR 820.25 (b). Specifically employees who manage, perform, and assess work affecting quality have not been adequately trained as members of your firm’s quality unit. Quality Assurance employees have not performed effectively in conducting complaint investigations, corrective/preventive action activities, design activities, internal audits, risk analysis and/or document reviews. You ran out of existing safety pins for the circumcision tray and a larger safety pin was substituted. You received at least two customer reports of excessive bleeding. The change to the larger safety pin was made by the Product Family Coordinator (PFC). The product authorization form was not signed and did not proceed through the change process. Other examples of inadequate employee training are the failure to implement adequate corrective and preventive actions to complaints of crystallizing alcohol in kits and a complaint of weak seals.

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Warning Letter: No documentation of employee training (s6597c)

Tags: Inadequate/Missing Procedures | No procedure for Internal Audits | No Procedure for Training
November 29, 2007

Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b). For example, there is no documentation of any training of any current employees with regard to their assigned responsibilities, although your training procedures require documentation of training. … Failure to conduct quality audits; and failure to implement audit procedures to assure that the quality system is in compliance with the established quality systems requirements and to determine the effectiveness of the Quality Systems, as required by 21 CFR § 820.22.

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Warning Letter: Employees not adequately trained (ucm076532)

Tags: Computer System | Design Validation Inadequate | Medical Device Manufacturer | No Procedure for Training
October 10, 2007

Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). For example: “a. Training records for a sterilizer operator and packager were requested at your Asheboro, NC, facility during the 2007 FDA inspection. Out of five (5) training records requested for the sterilizer operator, only two (2) were available. Two (2) training records were requested for the packager and only one (1) record was available.” “b. A number of documents were collected demonstrating that employees were not adequately trained, at your [redacted] facility.

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Warning Letter: Uncontrolled database (m4116n)

Tags: Clinical Research Organization | Database | No Audit Trail | No Procedure for Training
August 30, 2000
 
"...It is also noted in the inspection report that you do not have adequate control over the receipt of study data and its subsequent input into the database. There are no records to show when study data is received and when it is entered into the database. There is also no . No data queries or clarifications have ever been generated and sent to the sites to verify missing information or to clarify discrepancies... , Electronic Database Maintenance, are subject to 21 CFR Part 11- Electronic Records; Electronic Signatures, as well as to the record keeping regulations found in 21 CFR 812.140. A guidance document regarding this regulation, Computerized Systems Used in Clinical Trials, dated April 1999. www.fda.gov/ora/compliance ref/bimo/ffinalcct.htm"

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