FDA 483 Letters- 2017 review

 

You really don't want to receive this letter from the FDA. As of August 1, 2017, 248 FDA 483 letters have been issued and Calibration and measurement are specifically called out in 13 letters.

 

What are the common issues for those receiving an FDA 483 letter that mentions calibration?

  • Lack Of Adequate Documentation
  • Inadequate Procedures Addressing Calibration
  • Past Due Calibration
  • Lack Of Or Improper Training

 

Here are some snippets from FDA 483 letters issued in 2017:

 

INSPECTIONS AND COMPLIANCE

Read your calibration report:

Your firm failed to investigate and identify any actions needed to evaluate the impact of the (b)(4), ID # C5003 after a calibration service provider reported it “failed as found”. This flow meter was used in routine device acceptance activities to calibrate the (b)(4) adjustments of your Criticare patient monitors.

Stay on Schedule:

Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain written records of calibration checks and inspection of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).

Understand the measurement device:

Specifically, you were not calibrating your pH meter according to the directions stated in the user manual. On 01/12/2017, you demonstrated how to calibrate the pH meter by placing the pH meter in a (b)(4) buffer solution first and a (b)(4) buffer solution second, which were both at room temperature. You stated there is no particular order for which buffer solution to use first; you just grab and use whatever is closest. You did not have the owner’s manual for your pH meter at the start of the inspection.

If it is not in writing it didn't happen:

You failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing your dietary supplement, as required by 21 CFR 111.25(a). Additionally, you failed to calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). Specifically, you have not established and followed written procedures for calibrating instruments used in manufacturing your dietary supplements, and you have never calibrated the weighing scale (b)(4) used to weigh components.

Once you have established the required written procedures, you must make and keep records of calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35. 

 

Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).

 

 

The BIG Picture... 13 mentions of calibration in Inspection Citations in 2017.

Learn from the mistakes of others. Avoid these issues.

Click the image below to download the Calibration Audit Check List.

Calibration Audit Checklist Download

 

Visit our International Standards used in Calibration page for more on standards used in calibration.

Phil Wiseman

Phil Wiseman

Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.

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