Where are you now? Intelligence Services > Competency Training > Related Warning Letters
Competency Training Related Warning Letters
These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.
TYA Pharmaceuticals, 2002-08-06
"There is no training program for employees in current Good Manufacturing Practice (GMPs) [21 CFR 211.251]."
Earlham College, 2002-07-29
"Failure to document training of the only laboratory person involved in drug testing as to specific methodology, instruments used, and the Current Good Manufacturing Practices (cGMP's) relevant to laboratory operation as required by 21 CFR 211.25."
Mississippi Blood Services, Inc., 2002-07-02
"Our investigator noted the training record checklists for two production laboratory employees did not use the defined checklists. One employee's record had three checklists, which differed from the procedure's checklist, while the other employee's record had two lists that differed. Your firm's Training Program, dated June 15, 1998, specifically defines the training record checklists to be used for training of production laboratory employees."
"There is no evidence an annual written test has been given to all laboratory personnel as required by the "Training Program" procedure for the production laboratory."
"There is no evidence that all laboratory personnel have been observed annually for performance competency as required by the "Training Program" procedure for the production laboratory and the "Training Program" procedure for the compliance department."
Ametek, Inc., 2002-04-25
"Your firm failed to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned duties as required by 21 CFR 820.25(b). For example, no one at your firm has received training in the Quality Systems Regulations, and is therefore, qualified to conduct training with respect to the Quality Systems Regulations."
| 
PDF file (179 KB)