# FDA 483 - Resource Optimization & Innovation LLC - November 29, 2016

Source: https://www.keypedia.com/records/483/resource-optimization-innovation-llc/91cab803-f072-4cee-9394-1e9f0554f56e

> FDA 483 for Resource Optimization & Innovation LLC on November 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resource Optimization & Innovation LLC
- Inspection Date: 2016-11-29
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details multiple deficiencies at an unnamed outsourcing facility producing sterile drug products, including Phenylephrine.

**Microbiological Contamination Prevention:**
*   Procedures for preventing microbiological contamination are not established or followed.
*   Smoke study (unidirectional airflow pattern evaluation) for the ISO 5 Laminar Airflow Workbench (LAFW) was inadequate, specifically regarding settling plate placement for monitoring filling and the complete hood environment.
*   Volumetric air sampling of the ISO 5 hood is not conducted during compounding operations.

**Environmental Monitoring (EM):**
*   EM sampling is not performed in all appropriate locations.
*   Surface sampling in the (b)(4) Room is not performed on all significant objects touched/handled during compounding (e.g., (b)(4) pumps, (b)(4) electronic tablets).
*   Multiple (b)(4) electronic tablets are used interchangeably without identification to track which have been monitored.

**Batch Production and Control Records:**
*   Batch records are deficient, lacking correct actual dates and times for compounding operations (e.g., Phenylephrine 100 mg/mL lots 38824, 39124, 39138, 39316).
*   Untrained personnel (Material Handler) were documented as performing compounding operations in sterile areas (e.g., Phenylephrine 100

## Related Documents

- [UNTITLED_LETTER - 2018-07-13](https://www.keypedia.com/records/untitled_letter/resource-optimization-innovation-llc/dc33dbc8-1bd5-4248-9d9b-e820f502b2da)
- [483 - 2019-04-04](https://www.keypedia.com/records/483/resource-optimization-innovation-llc/8614d287-a46f-474c-892c-e35f7e6b6e56)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.keypedia.com/companies/resource-optimization-innovation-llc/d9354f15-63a0-4635-a42b-3586044d38f3

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79