Biomedical Engineering Reference
In-Depth Information
dated 12 June 1998: “There were no procedures outlining
the frequency for calibrating the scales.”
26
For an instance of
not addressing required standards, see FDA Warning Letter
to BTI Filtration dated 7 February 2007: “. . . your fi rm does
not include the specifi cations for the equipment requiring
calibration.”
27
For an example of failing to address limits for accuracy
and precision, see FDA Warning Letter to ChemSource,
dated 15 November 2002:
The inspection revealed that your laboratory equipment
calibration program is inadequate in the following
ways: [. . .] Failure to have written procedures describing
specifi c calibration instructions, and limits. [. . .] Failure
to conform to the USP Section <41> for weight and
balance determination.
28
As an example of the failure to incorporate remediation
steps in the calibration procedure, see FDA Warning Letter
to B. Braun Medical dated 15 March 2006:
. . . personnel knowingly utilized [. . .] several balances
that were [. . .] out of calibration [. . .] In fact, your written
procedures do not discuss initiating an investigation
to determine whether product may have been impacted,
nor discuss corrective actions for equipment that does
not meet acceptable tolerance limits.
29
For an instance of not meeting documentation requirements,
see FDA Warning Letter to Dale Dental, dated 14 October
2004, pointing out the “Failure to [ensure] that calibration
records are maintained.”
30
The calibration procedure involved in the illustrative study
presented in this chapter was found to meet all these
