# FDA 483 - Contract Pharmaceuticals Limited Canada - November 03, 2023

Source: https://www.keypedia.com/records/483/contract-pharmaceuticals-limited-canada/ebab7440-da3e-4a25-ac3c-92bd561a31fc

> FDA 483 for Contract Pharmaceuticals Limited Canada on November 03, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contract Pharmaceuticals Limited Canada
- Inspection Date: 2023-11-03
- Product Type: Biologics
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 document outlines observations made during an inspection of a facility involved in the production of sterile drug products. The inspection revealed several deficiencies related to quality systems and manufacturing controls.

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 discrepancies and failures found in batch production records. This indicates a weakness in their quality system's ability to identify root causes of issues and implement effective corrective and preventive actions (CAPA).

Finally, Observation 4 states that the firm did not maintain complete and accurate records of the cleaning and maintenance of equipment. Inadequate record-keeping for cleaning and maintenance can lead to equipment malfunction, cross-contamination, or ineffective cleaning, all of which can compromise product quality and safety.

These observations collectively point to significant deficiencies in the firm's quality control, validation, investigation, and record-keeping practices, which are fundamental requirements for the manufacturing of sterile drug products.

## Related Documents

- [483 - 2023-11-03](https://www.keypedia.com/records/483/contract-pharmaceuticals-limited-canada/e213dada-8783-40f0-9055-9b6e148e8c4d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)

Company: https://www.keypedia.com/companies/contract-pharmaceuticals-limited-canada/02ec2d1f-df8d-4636-95d2-b548aea571d8

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe