FDA Warning Letters


  1. Warning Letter: Faliure of validation process (ucm170224)

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    Your company did not ensure that its design verification and validation process detected design discrepancies with [redacted] the [redacted] printed circuit board (PCB) of the MTS trial stimulators using the [redacted] components that later caused loss of stimulation, and therefore, failure to complete trial implants.

    View the original warning letter.


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  2. Warning Letter: Failure to test input/output (ucm173977)

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    Failure to check input to and output from the computer or related systems of formulas or other records or data for accuracy as required by 21 CFR 211.68 (b). Specifically, duplicate donor records were created when your firm changed from [redacted] Computer System to [redacted] Computer System on December 2, 2008. The duplicate donor records do not always agree regarding donor eligibility status. For example,  The donor cited in Item 1 is assigned a [redacted] donor identification number of [redacted] and has an eligibility status of “indefinitely deferred”. The same donor has a [redacted] identification number of [redacted] and has an eligibility status of “eligible”.

    •  The final disposition of the leukocytes reduced red blood cells and recovered plasma components processed from this unit were not documented in your firm’s computer system and on the Blood Donation Record as required by SOP.
    •  You received confirmatory positive Recombinant Immuno Blot Assay (RIBA) and positive HCV-Nucleic Acid Testing (NAT) results for this donor on June 10, 2008. However during the current FDA inspection, this donor’s eligibility status was listed as “eligible” in your [redacted] Computer System.

    View the original warning letter.


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  3. Warning Letter: Failure to validate software (ucm173977)

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    Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system as required by 21 CFR § 820.70(i). This was a repeat violation from a previous FDA-483 that was issued to your firm. For example: A) Your firm uses off-the-shelf software (HEAT Help Desk) to manage customer support service calls and to maintain customer site configuration information; however, your firm failed to adequately validate this software in order to ensure that it will perform as intended in its chosen application. Specifically. your firm’s validation did not ensure that the details screen was functioning properly as intended. The details screen is used to capture complaint details and complaint follow-up information which would include corrective and preventative actions performed by your firm when service calls are determined to be CAPA issues. B) Off-the-shelf software (Microsoft SharePoint) is being used by your firm to manage your quality system documents for document control and approval. However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses. Specifically. at the time of this inspection there were two different versions of your CAPA & Customer Complaint procedure, SOP-200-104; however, no revision history was provided on the SharePoint document history. Your firm has failed to validate the SharePoint software to meet your needs for maintaining document control and versioning.

    View the original warning letter.


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  4. Warning Letter: Software not validated (ucm165771)

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    Some system components on the part lists were not depicted on the [redacted] drawings of the water purification systems installed at the [redacted] dialysis sites. Your computer software used to perform the [redacted] calculations has not been validated.

    View the original warning letter.


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  5. Warning Letter: Inadequate validation (ucm164129)

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    Failure to observe, standardize, and maintain equipment and failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements for blood and blood components [21 CFR 606.60(a)]. Specifically, the following observations were made during review of your firm’s validation of the interface between the automated blood testing instrument [redacted] and the database system, [redacted]

    • Validation sample testing and data collection was conducted on December 9, 2008, prior to approval of the validation test plan on. December 19, 2008;
    • The validation pass/fail criteria was not met;
    • The validation test plan was not followed; and
    • The validation data was incomplete.

    View the original warning letter.


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  6. Warning Letter: Inadequate electronic documentation system (ucm162970)

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    Specifically, your firm creates and stores all written information as electronic files and you do not keep any hard copies of these records. Your electronic documentation system does not meet system validations, system access limitations, audit trails, signature manifestations, and signatures to record linking requirements to ensure they are trustworthy, reliable and generally equivalent to paper records as required by 21 CFR Part 11.

    View the original warning letter.


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  7. Warning Letter: Database validation (ucm162745)

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    Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing and holding of a drug product. [21 CFR 211.68]

    The Enterprise Resource Planning System known as the firm’s Systems Applications and Products (SAP) computer database allows rejected batches of drug product to be in Unrestricted Status (to be released for distribution).

    During the inspection, you provided our FDA investigators a spreadsheet that you stated contained data for calibration of [(b)(4)], however, you were not able to provide the raw calibration data. In addition, the calibration data for the [(b)(4)] that you provided in your December response in Attachment #9 do not correspond to the [(b)(4)] observed by our FDA investigators.

    View the original warning letter.


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  8. Warning Letter: No validation of calculations (ucm162874)

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    Failure to maintain a written record and appropriate of computer or other automated processes used to perform calculations in connection with laboratory analysis [21 CFR § 211.68(b)]. Refer to FDA 483, Observation 12. For example, the accuracy of calculations performed by the [redacted] Spectrophotometer has not been verified.

    View the original warning letter.


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  9. Warning Letter: Spreadsheet Calculations not Verified or Documented (ucm174100)

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    Your laboratory records did not include a record of all calculations performed in connection with laboratory tests as required by 21 CFR § 211.194(a)(5). For example, laboratory notebook #7, page 49, documents the assay results, but not the calculations performed in Test number DSFS D-13 and Test number TG 521 for the analysis of [redacted], lot #HI7908. The notebook does not document reference to the spreadsheet calculation used to generate the results. In addition, the assay results generated by the spreadsheet were not verified for accuracy. Your response dated February 16, 2009, states that you have established procedures to ensure that calculations of method validation studies are recorded. The Records Management SOP, Section 5.7.4.7, states that the procedures shall define what and how data is to be recorded in respective logbooks. However, this SOP omits instructions to include in the notebook the reference to the spreadsheet calculation used to generate the results, as well as the raw data and calculations. In addition, you continued to release products based on assay results generated by the spreadsheet that have not been verified for accuracy.

    View the original warning letter.


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  10. Warning Letter: Failure to establish procedures (ucm165301)

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    Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

    View the original warning letter.


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