# FDA 483 - Longbow First Aid Products Manufactory - April 20, 2018

Source: https://www.keypedia.com/records/483/longbow-first-aid-products-manufactory/b3d70a22-36f4-4f17-8cb0-257b396460a9

> FDA 483 for Longbow First Aid Products Manufactory on April 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Longbow First Aid Products Manufactory
- Inspection Date: 2018-04-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Longbow First Aid Products Manufactory, a drug product manufacturer in Guicheng, China, was cited for numerous significant deficiencies during an FDA inspection. Key issues include a lack of validated sterilization processes and sterility testing for sterile OTC products, inadequate component identity testing, and poor facility management regarding storage space and equipment cleaning. The firm also failed to maintain proper batch production records, implement a stability program, and follow instrument calibration procedures, indicating a broad breakdown in quality control and GMP compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/eric-dong/762c3fe2-593d-41b6-8903-7c354f732435)

Company: https://www.keypedia.com/companies/longbow-first-aid-products-manufactory/18ade290-cd25-4844-bcc6-b5182d7ff385

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