# FDA 483 - Unknown Company - August 09, 2017

Source: https://www.keypedia.com/records/483/unknown-company/c9125a20-c458-41ce-a15c-b212897a235f

> FDA 483 for Unknown Company on August 09, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2017-08-09
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection of a pharmaceutical manufacturing facility. The inspection identified three key deficiencies related to quality system and manufacturing controls.

Observation 1 notes the firm's failure to establish adequate procedures for the cleaning and maintenance of equipment. This indicates a potential risk to product quality and consistency due to improperly maintained or cleaned machinery.

Observation 2 states that the firm did not adequately validate the manufacturing process for Product X. This suggests a lack of documented evidence that the process consistently produces a product meeting its predetermined specifications and quality attributes, potentially impacting product efficacy and safety.

Observation 3 highlights that the firm did not have proper controls in place to prevent contamination of sterile products. This is a critical finding, as inadequate contamination controls for sterile products pose a significant risk of patient harm from microbial contamination, potentially leading to serious health consequences.

These observations collectively indicate deficiencies in the facility's quality management system, specifically concerning equipment control, process validation, and contamination prevention for sterile manufacturing. The firm is required to address these issues to ensure compliance with regulatory requirements and maintain product quality and safety.

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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

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