# FDA 483 - Vital Care Compounder, Inc - July 07, 2016

Source: https://www.keypedia.com/records/483/vital-care-compounder-inc/edd26f5b-7914-4083-ae90-49ae18ca66fd

> FDA 483 for Vital Care Compounder, Inc on July 07, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vital Care Compounder, Inc
- Inspection Date: 2016-07-07
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details numerous deficiencies at a drug manufacturing facility, primarily concerning the absence of a quality control unit and inadequate aseptic processing controls.

**Key Violations and Observations:**

*   **No Quality Control Unit:** The firm lacks a quality control unit responsible for approving or rejecting materials and products. A non-patient specific non-sterile oral liquid (C-Chloral Hydrate 100mg/mL) was produced with 10 times the required active ingredient, creating a super-potent product, which was not rejected. Potency testing on finished drug products is not performed, and retain samples are not maintained.
*   **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established or followed. An employee was observed aseptically processing eye drops in non-sterile gowning, exiting and re-entering the clean room without changing, and failing to wipe down sterile bottles or re-sterilize gloves.
*   **Facility and Equipment Hygiene:** A scale in the ISO 8 prep room contained white powder residue. Active ingredients from previous processing were also noted. The owner entered the ISO 8 prep room without wiping non-sterile goggles. Open trash receptacles were observed in classified areas, including near ISO 5 Glove Box and hood.
*   **Sterilization and Depyrogenation Validation:** The firm has not validated the autoclave sterilization process for rubber stoppers and terminally sterilized drug products. The sterilization

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## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Investigator](https://www.keypedia.com/people/grant-d-jones/6e54ff50-6648-410c-8af0-da0e3b09d5cc)

Company: https://www.keypedia.com/companies/vital-care-compounder-inc/2010dd7b-a5d9-48e3-b5b4-e0d3fd9aacd1

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