# FDA 483 - Wellness Pharmacy, Inc. - September 30, 2014

Source: https://www.keypedia.com/records/483/wellness-pharmacy-inc/14c3c9fa-1b80-488e-8f4e-fc4d3efe23e8

> FDA 483 for Wellness Pharmacy, Inc. on September 30, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wellness Pharmacy, Inc.
- Inspection Date: 2014-09-30
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 document outlines several significant observations made during an inspection, indicating a lack of adherence to Good Manufacturing Practices (GMP) for drug products, particularly those purporting to be sterile or pyrogen-free.

Key deficiencies include:
*   **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed.
*   **Equipment Sanitation:** Equipment and utensils are not sanitized at appropriate intervals, risking contamination that could compromise drug product safety, identity, strength, quality, or purity.
*   **Pyrogen Testing:** Batches of drug products purporting to be pyrogen-free are not laboratory tested to confirm conformance to pyrogen requirements.
*   **Personnel Protection:** Protective apparel is not worn as necessary to safeguard drug products from contamination.
*   **Facility Construction:** Buildings used for manufacturing, processing, packing, or holding drug products lack suitable construction to facilitate cleaning, maintenance, and proper operations.
*   **Aseptic Processing Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions.
*   **Drug Product Release Testing:** Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
*   **Equipment Calibration:** Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
*   **Stability Testing Program:** There is

## Related Documents

- [STATE_REFERRAL_LETTER - 2014-09-26](https://www.keypedia.com/records/state_referral_letter/wellness-pharmacy-inc/d577f9b6-dbff-478d-bb6d-b8672eaa7781)
- [483_RESPONSE - 2014-09-30](https://www.keypedia.com/records/483_response/wellness-pharmacy-inc/7cda5fb2-bf7f-4fa4-94f5-47ae0aa866bc)

## Related Officers

- [Independent Distributor](https://www.keypedia.com/people/patrick-c-dooley/5802631e-1de3-4932-b2b9-f15e1fc276c8)
- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.keypedia.com/companies/wellness-pharmacy-inc/335feec9-bc47-4b85-89f7-db1d53efdde0

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea