# FDA 483 - Grato Holdings, Inc. - August 28, 2008

Source: https://www.keypedia.com/records/483/grato-holdings-inc/fe13b09d-4fea-44d0-bd1e-eb1e6ab94676

> FDA 483 for Grato Holdings, Inc. on August 28, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grato Holdings, Inc.
- Inspection Date: 2008-08-28
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 inspection document identifies significant deficiencies in a drug manufacturing facility's quality control and production processes.

**Key Violations and Observations:**

*   **Lack of Process Validation (Repeat Observation):** The firm has no completed or documented process validation reports for any drug products, indicating a failure to validate manufacturing processes that could cause variability in in-process material and drug product characteristics.
*   **Inadequate Component/Container/Closure Release (Repeat Observation):** The firm does not withhold components, drug product containers, and closures from use until sampled, tested, examined, and released by the quality control unit. They rely on supplier Certificates of Analysis without validating the reliability of these analyses.
*   **Insufficient Batch Production and Control Records:**
    *   **Uninvestigated Discrepancies:** Multiple instances of unexplained discrepancies (e.g., metal shavings, duct tape in shoot, incorrect compounding, shattered glass near product) were noted in batch records without corresponding investigations or notification to quality assurance.
    *   **Incomplete Investigations:** Investigations into discrepancies did not extend to other batches or drug products that might have been affected. For example, an investigation into metal shavings did not determine if previous batches were impacted.
    *   **Delayed Reporting:** An incident was reported to Quality Control days after it occurred, with no documentation of earlier notification or decision-making.
*   **Lack of Equipment Identity in Batch Records:** Batch production records fail to

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## Related Officers

- [supervisor](https://www.keypedia.com/people/brent-hall/2ab0de6f-9e02-4fce-9592-ecf3f836af7f)
- [David L. Miser](https://www.keypedia.com/people/david-l-miser/a2b844cb-7d06-4425-b556-9f2ada66fdb7)

Company: https://www.keypedia.com/companies/grato-holdings-inc/c4d08434-07cf-4712-94fe-865ffad4ef6c

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79