# FDA 483 - Unknown Company - November 15, 2016

Source: https://www.keypedia.com/records/483/unknown-company/c730653e-e0a4-4702-aa6d-f27219ee0c0b

> FDA 483 for Unknown Company on November 15, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2016-11-15
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a facility. The inspection revealed three key violations related to quality control, process validation, and record-keeping.

Observation 1 indicates that the firm failed to establish an adequate quality control unit. This suggests a systemic issue with the oversight and management of quality processes within the operation.

Observation 2 highlights that the manufacturing process for Product X was not adequately validated. This is a critical finding as it implies that the firm cannot assure that the manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes. This could have significant business and operational implications, potentially leading to product recalls or regulatory actions.

Observation 3 notes that the firm did not maintain proper records of equipment cleaning and maintenance. This deficiency in record-keeping is crucial for demonstrating that equipment is suitable for its intended use and that cross-contamination risks are mitigated.

Collectively, these observations point to deficiencies in the firm's quality system and manufacturing practices, requiring corrective actions to ensure compliance with regulatory requirements.

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## Related Officers

- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b