# FDA 483 - KRS Global Biotechnology, Inc - March 17, 2014

Source: https://www.keypedia.com/records/483/krs-global-biotechnology-inc/fbccbbf3-fcf2-46ec-857a-fb87759eeaa8

> FDA 483 for KRS Global Biotechnology, Inc on March 17, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KRS Global Biotechnology, Inc
- Inspection Date: 2014-03-17
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 documents observations from an inspection, highlighting significant deficiencies in the facility's sterile drug product manufacturing processes.

**Facility and Operation Details:** The inspection observed the production of various sterile drug products, including Bimix #10 (Papaverine/Phentolamine), Dropedirol, Human Chorionic Gonadotropin, Cyanocobalamin, Carnitine (L), and Methionine/Inositol/Choline.

**Violations and Observations:**

*   **Sterilization Process Validation (21 CFR 211.113(b)):**
    *   Procedures 07.31.01 and 03.42.01 for sterilization and depyrogenation of vials and glassware lack full validation for all drug product contact surfaces.
    *   Specific examples include the absence of (b) (4) for auto dispenser transfer tubing, glassware, vials, and stoppers, and lack of validation using appropriate (b) (4) (b) (4).
    *   Depyrogenation of these items was not validated using a known endotoxin standard to demonstrate a three-log reduction.
    *   The firm does not perform or require (b) (4) to ensure proper function of the (b) (4) used to sterilize drug products from nonsterile components. An instance was observed on 3/5/201

## Related Documents

- [WARNING_LETTER - 2014-03-17](https://www.keypedia.com/records/warning_letter/krs-global-biotechnology-inc/f124663c-2589-4a5c-bd34-2d3edd1b9366)
- [483 - 2016-08-31](https://www.keypedia.com/records/483/krs-global-biotechnology-inc/174c49de-b5d3-4714-b601-96565efd66ea)
- [AMENDED_483 - 2019-08-06](https://www.keypedia.com/records/amended_483/krs-global-biotechnology-inc/2aa78260-6652-436d-ae7f-f1eb342c0ea2)
- [483 - 2017-10-23](https://www.keypedia.com/records/483/krs-global-biotechnology-inc/eae79292-89b6-4df7-94b5-e3d87ec5a456)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/krs-global-biotechnology-inc/334c87d8-3093-492d-858e-ba1665e860e6

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9