# FDA WARNING_LETTER - Fehling Instruments GmbH & Co. KG - June 18, 2015

Source: https://www.keypedia.com/records/warning_letter/fehling-instruments-gmbh-co-kg/418923dc-6028-493e-86a5-fadb681f8d43

> FDA WARNING_LETTER for Fehling Instruments GmbH & Co. KG on June 18, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Fehling Instruments GmbH & Co. KG
- Inspection Date: 2015-06-18
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On October 13, 2015, the FDA issued a Warning Letter to Fehling Instruments GmbH & Co. KG following a June 15-18, 2015, inspection. The inspection revealed that the firm's cardiac biopsy instruments, ronguers, bone punches, and scissor instruments are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100):** Procedures lacked requirements for data analysis, verification/validation of actions, information dissemination, management review submission, and documentation of activities. CAPA records were incomplete.
2.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198):** Procedures did not ensure documentation of oral complaints, formal unit review, uniform/timely processing, MDR reportability evaluation, or complete investigation records.
3.  **Failure in design control procedures (21 CFR 820.30(c), (f), (e)):** Lacked requirements for review/approval of design inputs, documentation of design verification results, and formal documented design reviews at appropriate stages.
4.  **Failure to document rework activities (21 CFR

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## Related Officers

- [Peter Skott](https://www.keypedia.com/people/peter-skott/10cb156f-7582-4faa-9cfb-a667932bd47d)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.keypedia.com/companies/fehling-instruments-gmbh-co-kg/5de69c57-56e8-4569-8e3e-8816ce90532e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c