# FDA 483 - Keystone Pharmacy - November 03, 2017

Source: https://www.keypedia.com/records/483/keystone-pharmacy/44a79c51-f265-4381-b553-f72a68de9be3

> FDA 483 for Keystone Pharmacy on November 03, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Pharmacy
- Inspection Date: 2017-11-03
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: This FDA Form 483 documents observations from an inspection of Keystone Pharmacy, a producer of non-sterile drugs, located at 4021 Cascade Rd SE Ste 50, Grand Rapids, MI 49546-3720. The inspection was conducted from October 17, 2017, to November 3, 2017, and the report was issued to David J. Miller, Pharmacist-In-Charge/Co-owner.

The primary observation noted was the production of highly potent drugs without adequate segregation and cleaning of utensils to prevent cross-contamination. Specifically:
A. There were no defined or labeled areas for storing "clean" and "unclean" drug production equipment/utensils, including small plastic containers reused for repackaging bulk chemical materials. Equipment like capsule filling trays, molds, spatulas, mortars, pestles, and spinners were stored on portable carts or in a 3-compartment sink in the cleaning area without status identification.
B. Small, reusable plastic containers used for repackaging bulk chemical materials, including hormonal creams/ointments and excipients, were not dedicated, and there was no method to track or identify their previous contents after cleaning. An example cited was the use of such a container for testosterone in a prescription, with no way to determine its prior use.

## Related Documents

- [STATE_REFERRAL_LETTER - 2017-10-17](https://www.keypedia.com/records/state_referral_letter/keystone-pharmacy/d8ec72ed-0871-408e-abce-e673d7836e63)

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Constantin Y. Philopoulos](https://www.keypedia.com/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)
- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.keypedia.com/companies/keystone-pharmacy/f5df0ad4-61e2-444f-a9e2-4dd1a368d8c3

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03