# FDA WARNING_LETTER - FSSB Chirurgische Nadeln Gmbh - September 20, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/fssb-chirurgische-nadeln-gmbh/90c916e1-f330-4ab0-b8c6-eaf306ab1b9b

> FDA WARNING_LETTER for FSSB Chirurgische Nadeln Gmbh on September 20, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: FSSB Chirurgische Nadeln Gmbh
- Inspection Date: 2012-09-20
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 29, 2013, the FDA issued a Warning Letter to FSSB Chirurgische Nadeln GMBH following an inspection from September 17-20, 2012, in Jestetten, Germany. The firm manufactures sterile and non-sterile needles and sutures, classified as devices under section 201(h) of the Act. The inspection revealed these devices are adulterated per section 501(h) due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820.

Violations include:
1.  Failure to control nonconforming product (21 CFR 820.90): The firm's procedure for nonconforming material was not followed, nonconformances during needle production were undocumented, and disposition of nonconforming needles lacked control, documentation, evaluation, or corrective/preventive actions.
2.  Failure to evaluate complaints for Medical Device Reporting (MDR) (21 CFR 820.198(a)(3)): The complaint procedure did not require evaluation to determine if events necessitated an MDR submission.
3.  Failure to validate computer software (21 CFR 820.70(i)): Software validation for custom automatic needle production machines was performed but not documented.
4.  Failure to establish statistical techniques for process and product acceptability (21 CFR

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/fssb-chirurgische-nadeln-gmbh/047ed4f9-6e56-45fd-8911-217ae366d6df

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7