# FDA WARNING_LETTER - Leisegang Feinmechanik-Optik GmbH - April 19, 2012

Source: https://www.keypedia.com/records/warning_letter/leisegang-feinmechanik-optik-gmbh/5c78c6a8-8103-4155-8515-5cce9db43d69

> FDA WARNING_LETTER for Leisegang Feinmechanik-Optik GmbH on April 19, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Leisegang Feinmechanik-Optik GmbH
- Inspection Date: 2012-04-19
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On July 11, 2012, the FDA issued a Warning Letter to Leisegang Feinmechanik-Optik GmbH following an inspection from April 16-19, 2012, in Berlin, Germany. The inspection revealed that the firm's Leisegang Optik Model 1 and 2 colposcopes are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). The devices are also misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include:
1.  Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)), with the existing manual being inadequate and a specific complaint's corrective action lacking verification/validation.
2.  Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), specifically regarding timeliness, MDR evaluation, investigation, and recordkeeping.
3.  Failure to review and evaluate all complaints to determine

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Thomas G. Williams](https://www.keypedia.com/people/thomas-g-williams/1278c82d-ea0b-46dc-a201-727101a768d1)

Company: https://www.keypedia.com/companies/leisegang-feinmechanik-optik-gmbh/511b6af6-3cab-4e5c-a4fa-f78443fb40fa

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861