# FDA EIR - Spoonamore Drug Co Inc - March 14, 2017

Source: https://www.keypedia.com/records/eir/spoonamore-drug-co-inc/77ebd071-35b0-4239-997e-4cf84e297bd3

> FDA EIR for Spoonamore Drug Co Inc on March 14, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Spoonamore Drug Co Inc
- Inspection Date: 2017-03-14
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Spoonamore Drug Co Inc, a 503A compounding pharmacy in Louisville, KY, was conducted from January 17 to March 14, 2017. This inspection, carried out under FDA guidelines for sterile drug and drug manufacturing processes, followed a previous inspection in 2015 that resulted in an FDA-483 and a Warning Letter. The current inspection identified several significant issues. Three objectionable conditions were cited on an FDA-483 form, including the firm producing intrathecal products from non-sterile ingredients without endotoxin control or final product testing, inadequate smoke studies for ISO 5 hoods failing to demonstrate dynamic airflow, and the use of non-sterile wipes in sterile compounding areas. Additionally, eight verbal discussion items were raised. Notably, the firm had not fully corrected two issues from the 2015 inspection: personnel in sterile areas wore inappropriate, non-sterile clothing, and antimicrobial effectiveness testing was not performed for sterile multi-dose products like Tri-Mix and Bi-Mix. Other concerns included the lack of complaint handling procedures, absence of equipment calibration protocols, and failures in documenting cleaning and filter maintenance for non-sterile compounding areas. Management committed to providing a written response to these findings within 15 business days.

## Related Officers

- [General Manager](https://www.keypedia.com/people/michael-p-sheehan/bb91f6d2-e3fb-488f-a502-7039f556449f)
- [recipient](https://www.keypedia.com/people/erik-k-mayes/d2d6845a-1f20-4a09-9300-91fed936dfd5)
- [Steven D. Williams](https://www.keypedia.com/people/steven-d-williams/42a9e2e0-f356-48f2-838f-143eb2a309ca)
- [other](https://www.keypedia.com/people/amanda-harding/788016eb-3833-4754-a439-147a328ec973)

Company: https://www.keypedia.com/companies/spoonamore-drug-co-inc/295ad8e6-4b39-4416-b084-00d09edb1d98

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22