# FDA 483 - american pharmacy of illinois, inc.  - October 28, 2015

Source: https://www.keypedia.com/records/483/american-pharmacy-of-illinois-inc/29f850a7-f851-441b-b040-d2ae095dc097

> FDA 483 for american pharmacy of illinois, inc.  on October 28, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: american pharmacy of illinois, inc. 
- Inspection Date: 2015-10-28
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: This FDA Form 483 document details multiple deficiencies observed during an inspection, primarily concerning the manufacturing and quality control of drug products, particularly those purporting to be sterile.

Key observations include:
*   **Control Systems:** Deficiencies in control systems necessary to prevent contamination or mix-ups.
*   **Personnel Clothing:** Inappropriate clothing for personnel engaged in drug product processing.
*   **Environmental Control:** Lack of adequate equipment for controlling air pressure, micro-organisms, dust, humidity, and temperature where appropriate.
*   **Aseptic Processing Areas:** Deficiencies in environmental monitoring systems, systems for maintaining equipment used to control aseptic conditions, and cleaning/disinfecting procedures for rooms and equipment.
*   **Sterilization Procedures:** Absence of established and validated procedures to prevent microbiological contamination of sterile drug products, including validation of the sterilization process.
*   **Product Testing & Release:** Failure to laboratory test each batch of sterile and pyrogen-free drug product for conformance. Additionally, testing and release for distribution do not include appropriate laboratory determination of identity and strength of each active ingredient prior to release.
*   **Stability Program:** Absence of a written testing program to assess drug product stability characteristics.
*   **Production Controls:** Lack of established time limits for production phases and no written procedures for production and process controls to assure identity, strength, quality, and purity of drug products.

These findings indicate significant issues across quality systems, manufacturing processes, and

## Related Officers

- [Senior Compliance Manager](https://www.keypedia.com/people/christina-a-miller/7893b145-2814-4443-a886-29881db45918)

Company: https://www.keypedia.com/companies/american-pharmacy-of-illinois-inc/08ac3e1e-8c20-4e66-b671-d723a3674ec8

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669