FDA Warning Letters


  1. Warning Letter: Failure to validate (ucm249221)

    Tags: | |

    You have failed to validate with a high degree of assurance, a process where the results cannot be fully verified by subsequent inspection and test, (21 CFR 820.75(a)). Specifically: You have not validated the preparation of the [redacted] bonding solution which is used to bond the [redacted] subassembly, a component of the Trima ACCEL disposable set; You have not validated the preparation of the [redacted] which is used to bond the [redacted]subassembly and [redacted] subassembly, components of the Spectra disposable sets.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  2. Warning Letter: Failure to provide validation (ucm253115)

    Tags: | |

    Failure to establish and maintain a design history file (DHF) for each type of device as required by 21 CFR 820.30(j). For example, the following documentation was not present: a) Formal documented reviews of the design results, b) The identification, validation, or where appropriate verification of design changes and, c) The results of the design validation, including identification of the design, date, and individuals performing the evaluation.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  3. Warning Letter: No documentation of software validation results (ucm247475)

    Tags: | |

    Documentation of all software validation results  for the i.v.STATION was not completed per your firm’s Design Control, (D R&D 33.00) and the Design and Development Planning (P R&D 01.01) procedures. For the [redacted]  software validation test, the output is to verify that the procedure was completed correctly and that the “bag contains the requested volume of the drug.” The test completion date and the volume of the drug were not recorded. Additionally, successful completion of the [redacted]software validation test is to verify “that the syringe contains the required volume of drug.” The completion date and the volume of the drug in the syringe were not recorded, per procedure, for this test as well.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  4. Warning Letter: System not validated (ucm243585)

    Tags: | |

    In addition, we remain concerned that your [redacted] adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is still not final. Critical issues (deviations) identified in your interim validation report during the inspection included the following, but is not limited to: lack of training for your [redacted] support team, incomplete SOPs and Work Instructions, and inaccurate data migration of legacy adverse experience cases from your previous adverse drug experience database, [redacted]. Currently, your [redacted] system does not display accurate clock dates on MedWatch forms for cases which were initially entered in [redacted] and later entered into [redacted] due to the receipt of additional information (follow-up) for the same cases. MedWatch forms printed out from [redacted] for these migrated cases are documented as initial 15-day reports, instead of follow-up reports. Also, the report date in Block B5 of the MedWatch form is the print date, not the actual date of submission. Shortcomings such as these affect the accuracy, reliability, consistency of the system and your firm’s ability to discern invalid or altered electronic records or make timely submissions to FDA as required.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  5. Warning Letter: Failure to provide adequate procedures (ucm242439)

    Tags: | |

    Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, you have no documentation of “white box” testing of the embedded device software for the Spine Six device as required by your firm’s design control procedure.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  6. Warning Letter: Failure to validate computer software (ucm256890)

    Tags: | |

    Failure to validate computer software for its intended use in production according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented as required by 21 C.F.R. § 820.70(i). For example, your firm failed to validate, according to established procedures, the automated mills and lathes that are used in the manufacturing of components for the PL5 2008 medical laser. Your firm installed [redacted]automated mills and one automated lathe during December, 2006 but your firm could not provide an established validation protocol for the validation of the automated systems or provide any documentation that showed the systems and their controlling software that were used in the manufacture of metal and plastic components of the PL5 Medical Laser were validated. 5. Failure to establish and maintain adequate procedures for validating the device design that includes software validation and risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g).

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  7. Warning Letter: Validation under operating conditions(ucm239018)

    Tags: | |

    Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). Your firm failed to perform design validation for the data analysis software used in the Cal Ver EP Evaluator to determine out of specification stability results for Verichem products.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  8. Warning Letter: Failure to implement record keeping system(ucm238115)

    Tags:

     
    "You must
    implement the record keeping system
    that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the receiving and storage critical control points to control histamines listed in your HACCP plan for histamine producing fish. Specifically, your firm does not record the presence of ice at the receiving and storage critical control points as listed in your plan. In addition, your firm does not maintain original sanitation records or records required by your firms HACCP plan for histamine producing fish. Your firm transcribes from the original records into a computer database and the original record is destroyed.

    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  9. Warning Letter: Software not validated (ucm239465)

    Tags: | |

    Failure to validate, for its intended use, computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has not validated the software used for generating product labels.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  10. Warning Letter: Spreadsheet data entry cells not locked (ucm229262)

    Tags: | | |

    We observed 8 of 9 worksheets where one or more tabs with formula cells were not locked. These worksheets were used for analyzing raw data from drug component and product samples, including [redacted]. Your firm’s SOP 100-G-0110, “Creation and Use of Templates,” stated that cells, in which data is entered, must be locked within their electronic template.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>