# FDA 483 - Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy - August 10, 2018

Source: https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/4fe20825-c194-409f-9116-3af6e88d4774

> FDA 483 for Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy on August 10, 2018. Product: N/A. 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: 2018-08-10
- Office Name: Chicago District Office
- Summary: The FDA Form 483 details observations from an inspection of a facility producing sterile injectable and ophthalmic drug products.

The facility's design and operation permit poor material flow, with materials entering the ISO 7 Buffer room directly from an unclassified area via a redacted opening. This includes sterile processing supplies like redacted syringes, sterile redacted spray bottles, sterile wipes, redacted pharmaceutical grade redacted, and zip-lock bags. This was observed during sterile production of Papaverine, Phentolamine, Alprostadil injectable lots 07302018@18 and 07302018@17 in the ISO 5 hood on July 30, 2018.

Non-sterile bulk solutions are held for extended periods without supporting documentation for hold times. Bulk stock solutions are prepared in an uncertified hood and stored in a redacted as an intermediary stock solution at redacted for up to redacted days without redacted. For example, redacted of Alprostadil stock solution, lot 07122018@9 (Beyond Use Date 08/26/18), produced on July 12, 2018, was used to produce sterile products through redacted in the ISO 5 hood on multiple dates in July 2018, without requiring the intermediary stock solution to be redacted prior to later use.

Multi-dose sterile drug products are prepared with extended beyond

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- [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 - 2017-09-19](https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/9b4e9bf1-1b26-4f7c-a3bb-cea1caff8fc8)
- [483 - 2018-08-10](https://www.keypedia.com/records/483/dolan-central-illinois-compounding-llc-dba-preckshot-professional-pharmacy/8fa6d0fa-7610-405f-a513-d5201a315364)

## Related Officers

- [Bei Y. He](https://www.keypedia.com/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

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/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669