# FDA WARNING_LETTER - Sichuan Friendly Pharmaceutical Co., Ltd. - October 27, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/sichuan-friendly-pharmaceutical-co-ltd/86c804f6-a4c7-4976-ba26-92fa48e81979

> FDA WARNING_LETTER for Sichuan Friendly Pharmaceutical Co., Ltd. on October 27, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sichuan Friendly Pharmaceutical Co., Ltd.
- Inspection Date: 2017-10-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Sichuan Friendly Pharmaceutical Co., Ltd. following an inspection from October 23-27, 2017, identifying significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API), rendering their API adulterated.

Key violations include:
1. **Failure to conduct residual solvent testing:** The firm did not test for residual solvents (e.g., (b)(4)) in their (b)(4) USP API, despite using shared equipment and Class 2 solvents. Required actions include a comprehensive risk assessment, retention sample test results, and a plan for out-of-specification batches.
2. **Inadequate cleaning validation:** Cleaning procedures for non-dedicated equipment were not validated to prevent cross-contamination. The firm's validation was insufficient, only using one challenge product on a limited number of equipment pieces and not addressing residual solvent carryover. The FDA requires updated cleaning validation for all multi-use equipment and a comprehensive risk assessment.
3. **Insufficient stability testing program:** The firm lacked data to support the (b)(4) shelf-life of their (b)(4) API and did not use stability-indicating methods. The FDA demands an updated stability program and retention sample test data using appropriate methods.
4. **Inadequate controls over computerized systems:** A non-validated Excel spreadsheet with incorrect, unlocked formulas was used for assay calculations, leading to inaccurate Certificates of Analysis and out-

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