Warning Letter: Failure to maintain quality system requirements (ucm152423)

Tags: Failure to Validate | Inadequate/Missing Procedures | Medical Device Manufacturer | No Procedure for CAPA
January 6, 2009

Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 21 C.F.R. § 820.20(b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements. Additionally, you stated that your quality system has not kept pace with the growth of your firm’s business.

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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: Incomplete requirements (ucm075276)

Tags: Computer System | Inadequate/Missing Procedures | Medical Device Manufacturer | No Procedure for CAPA
February 7, 2005

Your firm failed to address design input requirements that are incomplete, as required by 21 CFR 820.30(c) [FDA-483, Item 31. Specifically,

• Functional requirements for the DBSS are in some cases very high level. For example, the requirements for Donor Reporting merely state that the application must enable the user to identify, from a list of persons, the donor on whom the report should be based, and to print an Autologous Unit Status Report, a Donor History Report, a Person Audit Trail Report, a Deferral Audit Trail Report, and an Individual Donor Orders Report for a specific donor. The requirements do not address the files to be accessed, the fields to be printed, or the format of the ave been written for problems with these reports. [redacted] have been written for problems with these reports. For example, [redacted] concerns the military personnel’s SSN appearing where the donor’s SSN should appear on the Donor Audit Trail Report.”

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Warning Letter: Failure to Create Validation and CAPA Procedures (g4452d)

Tags: Computer System | Failure to Validate Software | Medical Device Manufacturer | No Procedure for CAPA | Spreadsheet
December 23, 2003

Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) and (b). For-example:

a. The procedure titled corrective Action Handling [redacted] was not approved and implemented to address corrective and preventive action and no established procedure was found to have been in place.

b. Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program.

A report dated November 11, 2002 on non-conforming material on [redacted] was filed and a possible cause for the [redacted] was given; however no documentation was provided to verify or validate the adequacy of the corrective and preventive actions.

Problems were recorded relating to the use of the new dosing/dispensing machine [redacted]; however no documentation/evidence was provided
to verify or validate the adequacy of the corrective and preventive actions.”

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Warning Letter: Lack of system controls (g1113d)

Tags: Inadequate/Missing Procedures | Medical Device Manufacturer | No Procedure for CAPA
April 9, 2001
 
References electronic records (custom database, global action plan) - "The inspection revealed that the within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or , processing, packing, storage or distribution are not in conformance with the requirements of the Quality System Regulation..."

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Warning Letter: Nonconformance with 21 CFR Part 11 (m4105n)

Tags: Electronic Records | No Procedure for CAPA | Pharmaceutical Manufacturer
August 11, 2000

• In addition, we further request details regarding steps your firm is taking to bring your electronic CGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures.
• This inspection disclosed deficient controls in the laboratory electronic record keeping system, which is used for maintaining chromatography and audit trails.

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Warning Letter: Improper maintenance of electronic records (m2819n)

Tags: Computer System | Computer Systems Not Maintain | No Procedure for CAPA
July 21, 1999
 
"Failure to to include complete data derived from all tests necessary to and standards [2 1 CFR 211. 194]. Specifically, your firm failed to properly maintain electronic files containing data secured in the course of tests from 20 HPLCS and 3 GLCS. Additionally, no investigation was conducted by your company to determine the cause of missing data and no corrective measures were implemented to prevent the recurrence of this event."

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