# FDA 483 - Changzhou Maokang Medical Products Co., Ltd - August 24, 2018

Source: https://www.globalkeysolutions.net/records/483/changzhou-maokang-medical-products-co-ltd/0dcb821d-f3e1-485a-b544-fcf4912db9c2

> FDA 483 for Changzhou Maokang Medical Products Co., Ltd on August 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Changzhou Maokang Medical Products Co., Ltd
- Inspection Date: 2018-08-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Changzhou Maokang Medical Products Co., Ltd, a contract manufacturer in Changzhou, China, was cited for significant deficiencies in laboratory record-keeping and drug product release testing. The inspection revealed issues with incomplete electronic data, discrepancies between printed and electronic records, and a lack of proper review procedures for analytical data. Additionally, the firm's testing methods for drug product release were found to be inadequate, failing to ensure conformance to final specifications.

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.globalkeysolutions.net/companies/changzhou-maokang-medical-products-co-ltd/843526e8-61c6-485d-9999-98ddbc856d57

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1