# FDA 483 - The Wellness Pharmacy - March 12, 2015

Source: https://www.keypedia.com/records/483/the-wellness-pharmacy/244540cd-f98b-4c7d-ad25-28064c32418f

> FDA 483 for The Wellness Pharmacy on March 12, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Wellness Pharmacy
- Inspection Date: 2015-03-12
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection from March 9-12, 2015, The Wellness Pharmacy LLC, a sterile drug producer located at 2228 Papermill Rd Ste E, Winchester, VA, was cited for multiple violations. Russell T. Lederhouse, Owner, was issued the Form 483.

Key observations include:
1.  **Lack of Sterility and Endotoxin Testing:** No sterile parenteral product produced since 2013 has been tested for sterility or endotoxins.
2.  **Deficient Microbiological Contamination Prevention Procedures:**
    *   Sterile drug products were produced using (b)(4) without further steps to remove endotoxin or microbial contamination, and the system was not validated.
    *   Non-sterile patient isolation gowns and non-sterile latex gloves sprayed with a (b)(4) solution were used in sterile parenteral drug production.
3.  **Deficient Control Systems:**
    *   The (b)(4) for sterile parenteral products was in an unclassified area with (b)(4) allowing outside air entry.
    *   No procedure for adequate (b)(4) disinfection.
    *   The (b)(4) contained multiple objects impeding laminar air flow (e.g., red container, IV bar, plastic trays, non-sterile (b)(4) jar).
    *   Trash receptacle in the (b)(4) was full

## Related Documents

- [483_RESPONSE - 2015-03-12](https://www.keypedia.com/records/483_response/the-wellness-pharmacy/cae9f27a-4f64-42e5-b925-73b533b43a26)
- [483 - 2017-05-16](https://www.keypedia.com/records/483/the-wellness-pharmacy/0993ab2a-dffb-4201-acf5-c2e56b6db1d5)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/the-wellness-pharmacy/c8db9164-7349-4ed1-820c-7b244cc05af2

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa