# FDA 483 - WellRx LLC - November 19, 2015

Source: https://www.globalkeysolutions.net/records/483/wellrx-llc/847069d4-a2d5-4f3b-a592-5c79013e88ed

> FDA 483 for WellRx LLC on November 19, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WellRx LLC
- Inspection Date: 2015-11-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details observations from an inspection of Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy, a producer of sterile drugs, located at 200 E Willow Ave, Wheaton, IL. The inspection occurred from August 12, 2015, to November 19, 2015.

The inspection revealed numerous deficiencies across various aspects of sterile drug production:

**Product Quality and Contamination:**
*   **Observation 1:** A vial of sterile Chlorpromazine HCL 25mg/ml (lot# 05-070815) was observed with visible particles.
*   **Observation 2:** Procedures to prevent microbiological contamination during aseptic preparation were not established or followed, including lack of documented ISO-5 laminar air flow hood decontamination, failure to decontaminate sterile item packages before introduction into the hood, and opening sterile packages outside the hood.
*   **Observation 3:** Protective apparel worn by personnel during aseptic processing was inadequate (non-sterile gowns, masks, bonnets, booties; exposed skin; sterile gloves opened outside the hood).
*   **Observation 18:** The system for cleaning and disinfecting the cleanroom and equipment to produce aseptic conditions was deficient.

**Environmental and Personnel Monitoring:**
*   **Observation 4:** Aseptic processing areas lacked a system for monitoring environmental conditions. The firm had never performed environmental monitoring

## Related Documents

- [483_RESPONSE - 2015-11-18](https://www.globalkeysolutions.net/records/483_response/wellrx-llc/7f97f29c-f4c6-473d-969a-aeea6c762993)
- [483 - 2017-11-13](https://www.globalkeysolutions.net/records/483/wellrx-llc/5523d703-664d-4c9f-b93b-e7f70aa9c6a5)
- [STATE_REFERRAL_LETTER - 2017-10-02](https://www.globalkeysolutions.net/records/state_referral_letter/wellrx-llc/200d1fbf-5e5e-4a9c-b5f3-d65abc40d2c9)
- [145 - 2019-04-03](https://www.globalkeysolutions.net/records/145/wellrx-llc/cec293b1-7164-4ada-8134-24407fac71d9)

Company: https://www.globalkeysolutions.net/companies/wellrx-llc/3134662f-5c0a-4a98-9e89-531da1cd4c65

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