# FDA 483 - Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy - September 19, 2017

Source: https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/9b4e9bf1-1b26-4f7c-a3bb-cea1caff8fc8

> FDA 483 for Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy on September 19, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy
- Inspection Date: 2017-09-19
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: This FDA Form 483 details observations from an inspection of Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy, a producer of sterile drugs located at 5832 N. Knoxville, Ave., Suite E, Peoria, IL 61614. The inspection was conducted from June 12, 2017, to September 15, 2017.

Key observations include:

1.  **Drug Product Quality/Purity:** The firm released drug products (four lots of Tacrolimus 0.02% Oil Ophthalmic Solution and one lot of Cyclosporine Oil Ophthalmic Solution) where the strength, purity, or quality was deficient. This was due to the use of apparent food-grade ingredients, specifically [(b)(4)] and [(b)(4)], in their production.

2.  **Sterilization Process Validation:** Procedures to prevent microbiological contamination lacked adequate validation. Observations included a pharmacy technician cleaning multiple vials with the same side of a sterile wipe, and the technician had not undergone a media fill validation since September 13, 2016, despite releasing sterile products since October 28, 2015.

3.  **Aseptic Area Cleaning/Disinfection:** The system for cleaning and disinfecting aseptic processing areas and equipment was deficient. The ISO 7 gowning/anteroom failed ISO certification testing (integrity/[(b

## Related Documents

- [483 - 2015-05-14](https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/24486ed6-0d16-449d-bef4-dcbe7be2ba33)
- [483 - 2018-08-10](https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/8fa6d0fa-7610-405f-a513-d5201a315364)
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## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Consumer Safety Officer](https://www.keypedia.com/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.keypedia.com/companies/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/5b1453bc-b9d7-45dd-a744-4ca5a080b6db

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