# FDA 483 - Unknown Company - July 19, 2018

Source: https://www.keypedia.com/records/483/unknown-company/c45f4ad1-3871-4cea-9f42-8d41e5d392d0

> FDA 483 for Unknown Company on July 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2018-07-19
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: This FDA Form 483 document details observations made during an inspection, indicating deficiencies in the firm's operations related to drug manufacturing.

**Observation 1:** The firm failed to establish adequate procedures for cleaning and maintenance of equipment. This suggests a lack of documented and implemented protocols to ensure that manufacturing equipment is properly cleaned and maintained, which is critical for preventing cross-contamination and ensuring product quality.

**Observation 2:** The firm did not adequately validate the manufacturing process for Drug X. This indicates that the process used to produce Drug X has not been scientifically proven to consistently deliver a product meeting its predetermined specifications and quality attributes. Process validation is a regulatory requirement to ensure product quality and consistency.

**Observation 3:** The firm did not have proper controls in place to prevent contamination of products. This is a critical finding, implying a failure in the firm's quality system to implement effective measures against various sources of contamination (e.g., microbial, particulate, cross-contamination from other products). This deficiency poses a significant risk to product safety and efficacy.

Collectively, these observations highlight issues within the firm's quality system, specifically concerning equipment management, process control, and contamination prevention. These findings suggest potential non-compliance with current Good Manufacturing Practices (cGMP) regulations, which could have significant business and operational implications, including potential regulatory action and impact on product marketability.

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## Related Officers

- [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa