# FDA 483 - Unknown Company - June 15, 2012

Source: https://www.keypedia.com/records/483/unknown-company/b12f6c4e-c00c-44a5-84f6-b2048082a9bf

> FDA 483 for Unknown Company on June 15, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2012-06-15
- Office Name: Detroit District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection identified four key deficiencies related to the facility's quality system and manufacturing operations.

Observation 1 indicates that the firm failed to establish an adequate quality control unit, which is a fundamental component of a robust quality management system. This suggests a systemic issue in overseeing and ensuring product quality and compliance.

Observation 2 notes that the manufacturing process for Drug X was not adequately validated. Process validation is critical to ensure that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes. This deficiency could lead to variability in product quality and potential non-conformance.

Observation 3 highlights that the firm did not maintain proper records of equipment maintenance. Accurate and complete maintenance records are essential for demonstrating that equipment is fit for use, properly calibrated, and maintained to prevent contamination or malfunction, which could impact product quality.

Finally, Observation 4 states that the firm did not conduct adequate training for employees on Good Manufacturing Practice (GMP) requirements. Insufficient GMP training can lead to deviations from established procedures, errors in manufacturing, and a general lack of understanding of regulatory expectations, posing risks to product quality and patient safety.

These observations collectively point to significant deficiencies in the firm's quality control, process validation, record-keeping, and employee training programs, all of which are critical for compliance with GMP regulations and ensuring the quality and safety of manufactured drug products.

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## Related Officers

- [Rebecca E. Dombrowski](https://www.keypedia.com/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03