# FDA 483 - Unknown Company - July 13, 2018

Source: https://www.keypedia.com/records/483/unknown-company/9a61a742-34fb-4073-8894-88ea38872a10

> FDA 483 for Unknown Company on July 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2018-07-13
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 document details observations made during an inspection of a facility involved in the production of sterile drug products. The inspection revealed four key deficiencies related to the firm's quality system and manufacturing practices.

Observation 1 indicates a failure to establish an adequate system for monitoring environmental conditions within the aseptic processing area. This suggests potential risks to product sterility due to uncontrolled or unmonitored environmental factors.

Observation 2 highlights that the sterilization process for equipment used in sterile drug product production was not adequately validated. This is a critical finding as it directly impacts the sterility assurance of the final product, potentially leading to contaminated drug products.

Observation 3 notes that the firm did not conduct thorough investigations into batch discrepancies and failures. This indicates a weakness in the firm's corrective and preventive action (CAPA) system, potentially allowing recurring issues to go unaddressed and impacting product quality and consistency.

Finally, Observation 4 states that the firm did not maintain complete and accurate records of production and control activities. This deficiency affects traceability, accountability, and the ability to demonstrate compliance with good manufacturing practices (GMP), hindering effective quality oversight and potentially impacting regulatory submissions and product recalls.

Collectively, these observations point to significant deficiencies in the firm's quality control, validation, investigation, and documentation practices, all of which are critical for ensuring the safety, efficacy, and quality of sterile drug products.

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## Related Officers

- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9