# FDA 483 - Unknown Company - July 28, 2014

Source: https://www.keypedia.com/records/483/unknown-company/f215bb71-7b66-4e21-ae58-07e61320a691

> FDA 483 for Unknown Company on July 28, 2014. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Inspection Date: 2014-07-28
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection, indicating deficiencies in the facility's operations and quality system.

**Facility and Operation Details:** The document does not specify the name of the firm or the exact type of facility, but it indicates manufacturing operations, particularly involving "Product X."

**Violations and Observations:**
*   **Observation 1:** The firm failed to establish adequate procedures for the cleaning and maintenance of equipment. This suggests a lack of defined and effective protocols for ensuring equipment cleanliness and operational readiness, which is critical for preventing contamination and ensuring product quality.
*   **Observation 2:** The firm did not adequately validate the manufacturing process for Product X. This indicates that the process used to produce Product X has not been scientifically proven to consistently yield a product meeting its predetermined specifications and quality attributes.
*   **Observation 3:** The firm did not conduct proper training for employees on current Good Manufacturing Practices (cGMP). This highlights a deficiency in ensuring that personnel involved in manufacturing operations are adequately educated and proficient in the regulatory requirements and best practices for producing safe and effective products.
*   **Observation 4:** The firm did not maintain proper documentation for batch records. This suggests a failure to accurately and completely record all steps, materials, and results associated with the production of each batch, which is essential for traceability, quality control, and investigation of deviations.

**Regulatory Citations and Requirements:** While specific regulatory citations (e.g

## Related Documents

- [483 - 2011-05-05](https://www.keypedia.com/records/483/unknown-company/8f74a6dc-c0a5-4354-8036-3890202fc8eb)
- [RESUME - Unknown Date](https://www.keypedia.com/records/resume/unknown-company/f071af8e-ce6c-4c87-947b-39d97b8c2137)
- [483 - 2023-07-14](https://www.keypedia.com/records/483/unknown-company/ab0a6d0b-c0ca-4e02-82e2-ad2098b7fe12)
- [483 - 2017-08-09](https://www.keypedia.com/records/483/unknown-company/c9125a20-c458-41ce-a15c-b212897a235f)
- [483 - 2011-03-18](https://www.keypedia.com/records/483/unknown-company/da4f7d5a-691d-4aff-8e4f-02abadace162)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9