# FDA 483 - First Call Pharmacy, LLC - August 02, 2017

Source: https://www.keypedia.com/records/483/first-call-pharmacy-llc/1f0cd51d-5337-4af6-8183-a998dec57b75

> FDA 483 for First Call Pharmacy, LLC on August 02, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Call Pharmacy, LLC
- Inspection Date: 2017-08-02
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 documents observations from an inspection conducted on July 25-26, 2017, concerning aseptic production procedures. The facility was observed producing Vancomycin (Lot# 753653A) in 14/1gm, 8/1.5gm, 10/1gm, 14/1.5gm, and 14/2gm doses, and Ceftriaxone (Lot# 720068M) in 27/2gm doses.

Two key violations related to personnel aseptic technique were noted:
1.  **Exposed Hands:** On July 25, 2017, a sterile production technician was observed with bare hands exposed inside an ISO 5 laminar airflow hood while donning gloves, with another technician simultaneously engaged in sterile production nearby.
2.  **Exposed Mouth and Contamination Risk:** On July 25, 2017, a sterile production technician in the ISO 7 sterile production room was observed holding the door to the Ante Room open, with her face mask pulled below her chin, while communicating with the pharmacist-in-charge. The technician subsequently returned to performing procedures in the sterile production room without sterilizing her gloved hands, indicating a breach in aseptic protocol and potential contamination of the sterile environment.

## Related Officers

- [Investigator/Consumer Safety Officer](https://www.keypedia.com/people/francis-a-guidry/fd6d2a17-7f94-4f7c-8284-ad1f07d703e9)

Company: https://www.keypedia.com/companies/first-call-pharmacy-llc/698b6193-ee80-439b-b2bb-3ce2d4bef334

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9