# FDA WARNING_LETTER - Ningbo Poplar Daily-Use - February 13, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/ningbo-poplar-daily-use/8b795b7c-78c6-4d49-b6f7-48f21e1afff3

> FDA WARNING_LETTER for Ningbo Poplar Daily-Use on February 13, 2024. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Ningbo Poplar Daily-Use
- Inspection Date: 2024-02-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Ningbo Poplar Daily-Use, a manufacturer of OTC drug products, following a review of records submitted in response to a Section 704(a)(4) request. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include:
1.  **Failure to test finished drug products prior to release (21 CFR 211.165(a)):** The firm did not perform assay or (b)(4) testing on finished (b)(4) drug products. The provided "Drug Facts Label" was insufficient as specifications, and the test method using a hydrometer was unsuitable for the product matrix, violating 21 CFR 211.160(b). The FDA requires an action plan for full chemical and microbiological testing of retain samples for all in-expiry batches distributed to the U.S., with a summary of results and rapid corrective actions if substandard.
2.  **Failure to verify the identity of each component (21 CFR 211.84(d)(1)):** The firm did not demonstrate identity testing of incoming components, including (b)(4) for (b)(4) content. Only supplier test reports were provided, lacking scientific evidence of raw material conformity.
3.  **Failure to establish an adequate stability testing program (21 CFR 211.16

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/ningbo-poplar-daily-use/674ffc8e-b0b1-4e29-a1ac-18f6c884b333

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