# FDA 483 - John's Pharmacy Inc. - February 22, 2019

Source: https://www.globalkeysolutions.net/records/483/johns-pharmacy-inc/9b72166b-4134-428b-bf9e-a3476004db29

> FDA 483 for John's Pharmacy Inc. on February 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John's Pharmacy Inc.
- Inspection Date: 2019-02-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: John's Pharmacy Inc. in Sullivan, IL, a producer of non-sterile drugs, was cited for two significant issues during an FDA inspection. The firm used non-pharmaceutical grade water in drug production without microbial quality testing or proper maintenance records, and failed to adequately clean work surfaces and utensils when producing hazardous drugs, posing a risk of cross-contamination. These observations indicate deficiencies in component control and facility sanitation practices.

## Related Documents

- [483 - 2019-02-22](https://www.globalkeysolutions.net/records/483/johns-pharmacy-inc/7837ccfc-a401-4386-93e7-55da6b8bd6ff)

## Related Officers

- [Constantin Y. Philopoulos](https://www.globalkeysolutions.net/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)

Company: https://www.globalkeysolutions.net/companies/johns-pharmacy-inc/de7f2b42-46ba-4485-8270-bd4da8263798

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0