# FDA 483 - RC Compounding Services, LLC - February 16, 2018

Source: https://www.keypedia.com/records/483/rc-compounding-services-llc/05ff101f-4a7c-47af-9651-eed127936af8

> FDA 483 for RC Compounding Services, LLC on February 16, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RC Compounding Services, LLC
- Inspection Date: 2018-02-16
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 details observations from an inspection on February 12-13, 2018, concerning sterile drug production.

**Facility and Operations:** The facility produces sterile drug products, including Serum Tears, Testosterone Cypionate 200 mg for injection, and Epinephrine/Lidocaine Intraocular Solution 0.01 mg:20 mg/ml. Production occurs in ISO 5 Laminar Air Flow Hoods and ISO 7 cleanrooms/anterooms. Hazardous drugs like tacrolimus, testosterone, and progesterone are produced in the same ISO 5 hood as non-hazardous drugs.

**Violations and Observations:**
1.  **Airflow Obstruction:** On 02/12/2018, during Serum Tears production in the ISO 5 hood, an employee placed caps and containers in a pile, blocking first-pass ISO 5 airflow.
2.  **Non-Sterile Disinfectants/Wipes:** On 02/13/2018, non-sterile (b)(4) was used with sterile wipes to clean the ISO 5 hood. The non-sterile solution was also sprayed outside the hood, potentially entering the ISO 5 area.
3.  **Improper Gowning:** On 02/12/2018, an employee donned non-sterile gloves, then touched sterile gloves with them,

## Related Documents

- [WARNING_LETTER - 2013-02-07](https://www.keypedia.com/records/warning_letter/rc-compounding-services-llc/5940eb7a-e246-4c91-8cb1-12bef8e53f0f)
- [483 - 2013-02-07](https://www.keypedia.com/records/483/rc-compounding-services-llc/90d9f57c-0770-4410-bd17-5d9b935c4a0f)
- [483 - 2015-09-14](https://www.keypedia.com/records/483/rc-compounding-services-llc/39d27e37-dc66-45d0-b492-4af39be7fd84)
- [STATE_REFERRAL_LETTER - 2018-02-12](https://www.keypedia.com/records/state_referral_letter/rc-compounding-services-llc/165bb094-76d6-48d8-a08f-331ca7338376)

## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/rc-compounding-services-llc/e3565ac4-2470-4097-b815-163f83cc217a

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