# FDA 483 - Buffalo Pharmacies Inc - June 23, 2017

Source: https://www.keypedia.com/records/483/buffalo-pharmacies-inc/f556d4d8-aeb0-43e8-a257-7c656db251d8

> FDA 483 for Buffalo Pharmacies Inc on June 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Buffalo Pharmacies Inc
- Inspection Date: 2017-06-23
- Product Type: Drugs
- Office Name: New York District Office
- Summary: An FDA Form 483 was issued following an inspection of a drug product compounding facility. The inspection revealed several deficiencies related to aseptic processing and environmental controls.

**Violations and Observations:**

1.  **Inadequate Gowning Procedures:** The firm lacked a gowning procedure and aseptic processes to prevent contamination. A compounding technician was observed reusing a gowning jacket between multiple product preparations daily. The technician also donned gloves inside the ISO 5 laminar flow hood, exposing skin. Unfiltered air was introduced into a sterile bottle of Tacrolimus wet product via a syringe to create positive pressure.
2.  **Lack of Media Fills:** Procedures to prevent microbiological contamination were not established or followed, as the firm had not performed media fills to simulate aseptic production operations, including worst-case activities and conditions.
3.  **Deficient Cleaning and Disinfection:**
    *   Non-sterile wipes were used for sanitization of ISO 5 laminar flow hood surfaces.
    *   Sporicidal agents were not used in the cleanroom and ISO 5 area; non-sterile disinfectants were used instead.
4.  **Inadequate Environmental Monitoring:**
    *   Viable and non-viable monitoring of ISO 5 and ISO 7 areas was not conducted during dynamic processes. The firm lacked equipment for this testing and did not use an outside contractor. Only non-viable monitoring was performed under static conditions.
    *   Smoke studies were not performed under

## Related Documents

- [483 - 2018-07-26](https://www.keypedia.com/records/483/buffalo-pharmacies-inc/0415c6af-ec3b-44cf-87b0-265d5843b2f9)
- [STATE_REFERRAL_LETTER - 2018-07-24](https://www.keypedia.com/records/state_referral_letter/buffalo-pharmacies-inc/a553bf15-28e4-4546-98c4-adea9c0f3d76)
- [145 - 2019-09-16](https://www.keypedia.com/records/145/buffalo-pharmacies-inc/8781fcd2-a2cf-4dfe-938f-b331f4c53978)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-a-moliver/6130c1d8-9867-4da5-b113-1bbaf0ae9c79)

Company: https://www.keypedia.com/companies/buffalo-pharmacies-inc/9cc3565e-c9dc-45fd-b8a3-1b22e6d7352e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d