# FDA WARNING_LETTER - Rocket Medical Plc - July 14, 2011

Source: https://www.keypedia.com/records/warning_letter/rocket-medical-plc/2fd14cf0-d44e-4904-b571-d2aae321a6a4

> FDA WARNING_LETTER for Rocket Medical Plc on July 14, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rocket Medical Plc
- Inspection Date: 2011-07-14
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On October 13, 2011, the FDA issued a Warning Letter to Rocket Medical Plc following a July 11-14, 2011 inspection of their Washington, UK facility, which manufactures IVF devices. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Current Good Manufacturing Practice (CGMP) requirements.

The FDA cited five violations:
1.  **Failure to control device design (21 CFR 820.30(a)):** Design procedure SOP 2200 lacked requirements for design planning, inputs, outputs, verification, validation, transfer, and risk assessment. This was a repeat observation from a 2006 inspection.
2.  **Inadequate corrective and preventive actions (CAPA) procedures (21 CFR 820.100(a)):** SOP 3104 did not include requirements for analyzing potential causes, investigating nonconformities, verifying/validating CAPAs, or disseminating quality problem information. Specific CAPAs (e.g., for IVF product testing failures and a catheter complaint) lacked documented investigations, implementation, or verification.
3.  **Failure to control environmental conditions (21 CFR 820.70(c)):** SOP

## Related Officers

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

Company: https://www.keypedia.com/companies/rocket-medical-plc/e491b833-ae68-4df9-9eef-8ae2a60da179

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