# FDA 483 - Safeway, Inc. - June 12, 2017

Source: https://www.keypedia.com/records/483/safeway-inc/4ad6d9c4-0cc3-49f2-8d50-88c1b9ebbaaa

> FDA 483 for Safeway, Inc. on June 12, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safeway, Inc.
- Inspection Date: 2017-06-12
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed four key deficiencies related to the firm's quality system and manufacturing processes for sterile drug products.

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 the production of sterile drug products was not adequately validated. This is a critical finding as it directly impacts the sterility assurance of the final product.

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 corrective and preventive action (CAPA) system and an inability to identify root causes of issues, potentially leading to recurring problems.

Finally, Observation 4 states that personnel involved in the manufacturing process were not adequately trained. This deficiency can lead to human error, non-compliance with procedures, and compromised product quality.

Collectively, these observations point to significant issues in the firm's quality control, process validation, deviation management, and personnel training, all of which are crucial for ensuring the safety, efficacy, and quality of sterile drug products. The business and operational implications include potential regulatory actions, product recalls, and damage to reputation if these deficiencies are not promptly addressed.

## Related Documents

- [483 - 2017-06-12](https://www.keypedia.com/records/483/safeway-inc/82d6f7ac-cac0-44c7-a700-60ef04b356b1)
- [STATE_REFERRAL_LETTER - 2017-06-05](https://www.keypedia.com/records/state_referral_letter/safeway-inc/62c0ab76-6c20-468a-b157-6ace8500ee4b)

## Related Officers

- [Haroon Vohra](https://www.keypedia.com/people/haroon-vohra/690c60b4-3059-4768-bfca-0cdabc58a72a)
- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

Company: https://www.keypedia.com/companies/safeway-inc/0e5bec08-2c7f-4fa4-b43d-54ef4ae575a5

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face