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Where are you now? Intelligence Services > Competency Training > Related Warning Letters

Competency Training Related Warning Letters

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PDF PDF file (179 KB)
TYA Pharmaceuticals, 2002-08-06
"There is no training program for employees in current Good Manufacturing Practice (GMPs) [21 CFR 211.251]."

PDF PDF file (266 KB)
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."

PDF PDF file (329 KB)
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."

PDF PDF file (185 KB)
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 PDF file (183 KB)
Titan Pharmaceuticals. Inc, 2002-04-15
"The failure of your staff to properly identify two similar investigational products in an accurate and consistent manner is indicative of systemic training and record keeping problems."

PDF PDF file (108 KB)
Pulmonaire Service, Inc., 2002-02-22
"Inadequate Good Manufacturing Practice training of firm personnel."

PDF PDF file (183 KB)
Medico Medical Equipment & Supplies, Inc., 2002-02-21
"Failure to provide and document medical gas GMP training for each individual responsible for medical gas transfilling and distribution operations."

PDF PDF file (415 KB)
Dumex Medical, 2002-01-24
"A Quality Assurance (QA) technician without documented training and proper authorization was releasing finished goods into finished goods inventory."
  "The QA Inspector responsible for testing and acceptance activities does not have any documented training prior to July 16, 2001, although the inspector has been employed since 1997."

PDF PDF file (122 KB)
Colombus Medical Equipment, 2002-01-23
"There are no established written procedures detailing training required by employees. Also, there is no documentation that employees received training in cGMPs."

PDF PDF file (391 KB)
Misonix, Inc., 2001-12-20
"Review of training records for employees responsible for testing of products revealed lack of training in the area of Quality System Regulations or on the quality policy. Training records lack detailed information, indicating what training was conducted, when the training was conducted and by whom."

PDF PDF file (518 KB)
Medical Device Services, Inc., 2001-12-13
"Employees performing internal quality audits and manufacturing tasks have not been trained in the Quality System Regulations that pertain to their areas of responsibility."

PDF PDF file (642 KB)
Cardinal Enterprises, Inc., 2001-12-07
"Various production personnel reported to our investigator that they had not read procedures relating to their assigned duties and had not been trained in current good manufacturing practice."

PDF PDF file (284 KB)
ADAC Laboratories, 2001-10-25
"The Quality System Regulation, 21 CFR 820.25(b), requires that you identify training needs and ensure that all personnel are trained adequately to determine their assigned duties. You should review your training program to determine if you are adequately identifying training needs, including periodic training updates to existing procedures if needed. Corrective actions should be initiated if your evaluation finds deficiencies."

PDF PDF file (126 KB)
AJD Laboratories dba Ulmer Pharmacal, 2001-10-02
"Failure to document training in current good manufacturing practices for employees in the manufacture of over-the-counter (OTC) drug products (21 CFR 211.25)."

PDF PDF file (334 KB)
Camtronics LTD., Medical Systems, 2001-09-19
"Your firm failed to establish adequate procedures for identifying training needs and to ensure that all personnel are trained to perform their assigned duties, including documentation of all training, as required by 21 CFR 820.25(b). For example, the individual responsible for most of the manufacturing has not received any in-house or formal QS/GMP training, and training received by employees is not documented."

PDF PDF file (252 KB)
Vital Concepts, Inc., 2001-09-18
"You failed to specify how initial training of new employees would be conducted, as required by 21 CFR 820.25, in your procedure Q003, 'Personnel'."
  "You failed to assure adequate ongoing training of employees in their job functions and quality systems required by 21 CFR 820.25. You did not use the TRAINING DOCUMENTATION form called for in revision "B" dated 3/1/98 of procedure Q003, "personnel", nor any other format, to document recent employee training."

PDF PDF file (241 KB)
Progeny, Inc., 2001-07-19
"Your firm had no procedures for training production line employees and the application engineer (for complaint handling responsibilities). Also, your firm had no documentation that the line employees and the applications engineer received adequate training to perform their assigned duties."

PDF PDF file (227 KB)
Aventis Bio-Services, 2001-06-29
"Failure of personnel to have a thorough understanding of the procedures or control operations they perform, and/or the necessary training or experience in their respective functions [21 CFR 606.20(b)]"
  "Employee training on the use of the new computer system, which is used in donor screening and product processing, was not complete. Employees were not very familiar with this computer system. Additionally, the center director had not received any training on this computer system even though he retains a high security level for data entered on this computer system."

PDF PDF file (213 KB)
Pharmatech, Inc., 2001-05-30
"There was no documentation describing the training and training needs for employees conducting your quality audit activities."

PDF PDF file (308 KB)
COATS Aloe International, Inc., 2001-05-01
"Management personnel responsible for overseeing manufacturing and testing of drug products have not received current Good Manufacturing Practices [CGMP] training. There are no records to demonstrate that approximately xxxxx employees hired within the past xxxxx months to perform drug activities have received CGMP training in their associated areas of responsibility."

PDF PDF file (318 KB)
Truett Laboratories, Inc., 2001-04-19
"You were unable to provide any training or qualification records for a technician in your quality control laboratory who conducts sampling and testing of raw materials and water sampling, among other things. This technician is currently enrolled in an undergraduate chemistry program."

PDF PDF file (449 KB)
Biological Research Solutions, Inc., 2001-01-16
"The training program fails to assure your employees and supervisory employees are trained in the specific tasks and in their assigned responsible functions: a) there are no written procedures for conducting training for specific tasks or for good laboratory practice training. 211.25(a); b) the training records do not sufficiently document that analysts have been trained for the specific tasks that they perform. 211.25(a); c) there is no documentation that management reviewed the adequacy of the training. 211.25(b)."

PDF PDF file (293 KB)
Unique Laboratories, Inc., 2000-11-13
"You have failed to ensure that each person engaged in the manufacture, processing, packing, or holding of your drug products, and each person responsible for supervision of these activities, has the education, training, and experience to enable that person to perform their assigned functions in such a manner as to provide assurance that your drug products have the quality and purity that they purport or are represented to posses. This training must not only be in the particular operations that the employee performs but also include current good manufacturing practice as it relates to the employee's functions. This lack of adequate training included production, quality control, and management personnel."

PDF PDF file (326 KB)
Sybron Chemicals, Inc., 2000-11-13
"Your formalized training program is inadequate in that it does not address current good manufacturing practices. There is no documentation that your QA/QC Laboratory personnel received any cGMP training."
  "We are concerned that you do not appear to understand the significance of training your employees in CGMP's."

PDF PDF file (482 KB)
Akorn Incorporated, 2000-09-28
"Failure to assure that all employees involved in the manufacture, processing, packing, or holding of a drug product have the education, training, and experience to enable them to perform the assigned functions as required by 21 CFR 211.25(a)......"

PDF PDF file (94 KB)
Gemeindezentrum, 2000-04-10
"Inadequate training of laboratory personnel. The employees were observed to be mouth-pipetting."

PDF PDF file (319 KB)
American Pharmaceutical Partners, Inc., 2000-02-07
"Employees have not received training on how to do airflow pattern tests."

PDF PDF file (187 KB)
Weber Laboratories, Inc., 2000-01-25
"The formal training of the analyst performing chemistry testing consists of one year of inorganic chemistry and one semester of organic chemistry. This analyst is involved in methods development and modification of established methods, In addition, there are no records documenting in house training of any personnel at the firm."

PDF PDF file (130 KB)
Pierre Fabre, Inc., 1999-11-05
"You hire temporary employees for the production of your drug products with limited manufacturing training and no documented cGMP training. In addition, your firm was unable to validate a compound bulk sampling procedure due to a 'lack of technical expertise'."

PDF PDF file (163 KB)
Chemrite Industries, Inc., 1999-10-19
"Training of management personnel is inadequate. No formal GMP training conducted by qualified individuals has been conducted."

PDF PDF file (325 KB)
PharmaScience Laboratories, LLC, 1999-09-21
"The production manager performed training of all personnel from April 27, 1999 to present, in spite of the fact that he hadn't received any CGMP training until July 14,1999, and no training records were available for the high school students who work part time at the firm."

PDF PDF file (242 KB)
Poli Industria Chimica S.p.A., 1998-08-24
"Your firm was cited for not having a formalized training program for employees regarding SOPs. In addition, we are quite concerned with the number of times your personnel had to be retrained in your written procedures and proper good manufacturing practices. Examples include: ....."

PDF PDF file (329 KB)
S. S. S./Pfeiffer Company, 1998-03-30
"There is no formal training program for the employees in the chemistry and microbiology laboratories to evaluate their analytical skills. One employee involved in the collection of environmental monitoring samples had never participated in a media fill and had no documented training other than viewing a video on aseptic filling."

PDF PDF file (838 KB)
Bayer Corporation, 1998-01-30
"Employees do not take part in a media fill prior to participation in routine filling."
  "There is no assurance that appropriate personnel are trained prior to implementation of new or revised procedures."

PDF PDF file (400 KB)
Watson Pharmaceuticals, Inc., 1998-01-28
"Our investigation disclosed that analyst(s) had not received sufficient training in determinative steps in analysis which they have been assigned to perform."

PDF PDF file (236 KB)
Perrigo Co., 1997-09-27
"Training of your managers as well as production and quality employees is important so that there is a clear understanding of Good Manufacturing Practices (GMP) requirements....."

PDF PDF file (275 KB)
Alra Laboratories, Inc., 1997-08-29
"At least two laboratory analysts were permitted to independently perform laboratory analyses without adequate training or supervision, and that their work is now being questioned."

PDF PDF file (255 KB)
Invacare Corporation, 1997-08-20
"Your QM stated that he had no formal training in GMP's, the QS regulation, process validation, design control and other areas that a person in this position would be required to manage. Your QM stated that he had a one day course in ISO 9000 which was documented, and was scheduled to attend a 2 day course on process validation."
  "The QM is obviously qualified for the position he holds and no one is disputing that, however, he obviously has received little training dealing specifically with the areas that he is directly responsible for supervising including: process validation, design control as it relates to manufacturing, finished device testing, corrective and preventive actions, failure investigations, complaint handling etc. Without documentation of these activities, there is no way for FDA to determine a person's ability to adequately manage and supervise."

PDF PDF file (611 KB)
Österreichishes Institut für Haemoderivate Ges.m.b.H., 1997-05-17
"There are no training records to document that the individuals who perform non-viable monitoring of the classified areas have been trained for the following procedures....."

PDF PDF file (517 KB)
Bayer Corporation, 1997-01-30
"CGMP training is not conducted on a continuing basis with sufficient frequency to assure that employees remain familiar with applicable CGMP requirements. Moreover, during an aseptic growning demonstration the aseptic operator was observed pre-assembling, and the sterile aseptic operator does not wear sterile gloves until fully growned."

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