# 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/8fa6d0fa-7610-405f-a513-d5201a315364

> 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: This FDA Form 483 was issued to Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy, located at 5832 N Knoxville Ave, Ste E, Peoria, IL 61614-4300, a producer of sterile and non-sterile drug products. The inspection, conducted from July 30, 2018, to August 10, 2018, identified five observations.

Observation 1 noted that the facility's design and/or operation permitted poor material flow, specifically, materials were brought into the ISO 7 Buffer room directly from an unclassified area via a b(4) for sterile processing supplies.

Observation 2 detailed that non-sterile bulk solutions were held for extended periods without supporting documentation for hold time. For example, Alprostadil stock solution, lot 07122018@9, was produced in an uncertified hood and stored for up to b(4) days without b(4) prior to b(4) after use, and was used in multiple sterile product lots.

Observation 3 stated that the firm prepared multi-dose sterile drug products without preservatives, but with extended beyond-use dates. Examples included Acetylcysteine Ophthalmic solutions (45 days frozen/refrigerated) and Tacrolimus in Corn Oil NF Ophthalmic solutions (28 days room temperature).

Observation 4

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- [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/4fe20825-c194-409f-9116-3af6e88d4774)

## 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