# FDA 483 - Unknown Company - November 18, 2010

Source: https://www.keypedia.com/records/483/unknown-company/c77a2fe8-08ad-4de2-8fc8-6a8823b39a5b

> FDA 483 for Unknown Company on November 18, 2010. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2010-11-18
- Product Type: Food
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed four key deficiencies related to the firm's quality control, manufacturing processes, record-keeping, and material testing.

Observation 1 indicates the firm failed to establish an adequate quality control unit, which is a fundamental requirement for ensuring product quality and compliance. Observation 2 highlights that the manufacturing process for Drug X was not adequately validated. This suggests potential issues with process consistency and product quality, as validation ensures the process consistently produces a product meeting its predetermined specifications.

Observation 3 notes the firm did not maintain proper records of equipment cleaning and maintenance. This lack of documentation can lead to cross-contamination risks and demonstrates a failure in maintaining equipment in a state of control. Finally, Observation 4 states the firm did not conduct adequate testing of raw materials before use in production. Insufficient raw material testing poses a significant risk to the quality and safety of the final drug product, as contaminated or substandard materials could be incorporated into the manufacturing process.

These observations collectively point to systemic issues within the firm's quality management system and manufacturing operations, indicating non-compliance with Good Manufacturing Practices (GMP).

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## Related Officers

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Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8