# FDA 483 - K.C. Pharmaceuticals, Inc - January 30, 2020

Source: https://www.globalkeysolutions.net/records/483/kc-pharmaceuticals-inc/62f4d6c3-b675-4e9c-b5a4-08a1a7831a2a

> FDA 483 for K.C. Pharmaceuticals, Inc on January 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: K.C. Pharmaceuticals, Inc
- Inspection Date: 2020-01-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: K.C. Pharmaceuticals, Inc. in Pomona, CA, a sterile OTC eye drop manufacturer, was cited for multiple deficiencies during an FDA inspection from January 22-30, 2020. The observations primarily concern inadequate investigations into discrepancies, insufficient microbial control, and a lack of established procedures for preventing contamination and validating manufacturing processes. These issues indicate significant concerns regarding the firm's aseptic processing and quality control systems.

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## Related Officers

- [Lisa R Weidley](https://www.globalkeysolutions.net/people/lisa-r-weidley/dc73966f-fc3a-4553-9ec6-7bbc48cadb98)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/kc-pharmaceuticals-inc/c82c2f64-5944-429b-a3a9-2f7a567e47d3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6