# FDA WARNING_LETTER - Central Surgical Co. Ltd. - August 14, 2012

Source: https://www.keypedia.com/records/warning_letter/central-surgical-co-ltd/f5d40b48-5e41-4389-8a9c-c0adcb991aea

> FDA WARNING_LETTER for Central Surgical Co. Ltd. on August 14, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Central Surgical Co. Ltd.
- Inspection Date: 2012-08-14
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On December 27, 2012, the FDA issued a Warning Letter to Central Surgical Co. Ltd. in London, United Kingdom, following an inspection on August 13-14, 2012. The inspection revealed that the firm's oocyte aspiration needles are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

The FDA identified four key violations:
1.  **Failure to validate processes (21 CFR 820.75(a)):** The firm's (b)(4) sterilization process was not validated, and documentation for initial validation was missing. The firm's response regarding re-validation was inadequate, lacking technical information.
2.  **Failure to establish corrective and preventive action procedures (21 CFR 820.100(a)(3)):** The firm failed to identify actions to correct and prevent recurrence when (b)(4) bio-burden limits were exceeded. The response was inadequate, lacking documentation of retraining and retrospective review of bio-burden results.
3.  **Failure to control production processes (21 CFR 820.70(a)):** (b)(4) sterilization batches in 2012 exceeded the specified load capacity of (

## Related Officers

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

Company: https://www.keypedia.com/companies/central-surgical-co-ltd/37a74575-d7d1-4beb-8cc7-25965147b937

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