# FDA 483 - RC Compounding Services, LLC - September 14, 2015

Source: https://www.globalkeysolutions.net/records/483/rc-compounding-services-llc/39d27e37-dc66-45d0-b492-4af39be7fd84

> FDA 483 for RC Compounding Services, LLC on September 14, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RC Compounding Services, LLC
- Inspection Date: 2015-09-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document, issued from June 23 to September 14, 2015, details observations made during an inspection of Raymond R. Carlson, Owner, RC Compounding Services, LLC, located at 1030 Center Rd, Poland, OH 44514-2150, a facility manufacturing sterile drug products.

The inspection revealed nine key observations:

1.  **Sterilization Process Validation Deficiencies:** Procedures to prevent microbiological contamination of sterile drug products lack validation of the sterilization process. This includes unvalidated processing methods for injectable drug products using [b(4)] and/or [b(4)] sterilization, lack of qualification documentation for the [b(4)] used, and no supporting studies for extended batch holding times (e.g., Dexamethasone 400 mcg/0.1 mL for [b(4)] and Trypan Blue 0.1% ophthalmic solution for [b(4)]). Additionally, the cleaning, sterilization, and depyrogenation methods for vials, stoppers, and caps used as container/closure systems for sterile injectables are unvalidated, and the [b(4)] used is unqualified. Media fills performed in the ISO 5 area do not accurately simulate actual production or challenging conditions.

2.  **Personnel Gowning Issues:** Personnel clothing for manufacturing sterile drug products is inappropriate. Sterile garb is hung on hooks in

## Related Documents

- [WARNING_LETTER - 2013-02-07](https://www.globalkeysolutions.net/records/warning_letter/rc-compounding-services-llc/5940eb7a-e246-4c91-8cb1-12bef8e53f0f)
- [483 - 2013-02-07](https://www.globalkeysolutions.net/records/483/rc-compounding-services-llc/90d9f57c-0770-4410-bd17-5d9b935c4a0f)
- [483 - 2018-02-16](https://www.globalkeysolutions.net/records/483/rc-compounding-services-llc/05ff101f-4a7c-47af-9651-eed127936af8)
- [STATE_REFERRAL_LETTER - 2018-02-12](https://www.globalkeysolutions.net/records/state_referral_letter/rc-compounding-services-llc/165bb094-76d6-48d8-a08f-331ca7338376)

## Related Officers

- [Executive Director](https://www.globalkeysolutions.net/people/janet-j-bowen/c7146abc-0842-4952-b9e1-7a9dbef2a35f)

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

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c