# FDA 483 - Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center - June 13, 2019

Source: https://www.keypedia.com/records/483/puget-sound-drug-corporation-dba-key-pharmacy-and-compounding-center/0d932830-b5b0-49b9-8b53-125a27c11d50

> FDA 483 for Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center on June 13, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
- Inspection Date: 2019-06-13
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 document outlines three observations made during an inspection of a pharmaceutical manufacturing facility. The facility is involved in the production of sterile drug products, specifically utilizing aseptic processing.

Observation 1 indicates a failure to establish an adequate system for monitoring environmental conditions within the aseptic processing area. This suggests a potential risk to the sterility of the drug products due to insufficient control over the manufacturing environment.

Observation 2 notes that the firm did not adequately validate the sterilization process for equipment used in the production of sterile drug products. This deficiency raises concerns about the sterility assurance of the equipment, which is critical for preventing contamination of the final product.

Observation 3 highlights that the firm did not conduct thorough investigations into discrepancies and failures found in batch production records. This indicates a weakness in the facility's quality system, specifically in its ability to identify, investigate, and resolve issues that arise during manufacturing, potentially leading to recurring problems or unaddressed quality concerns.

Collectively, these observations point to deficiencies in environmental control, sterilization validation, and quality system investigations, all of which are critical for ensuring the safety, quality, and sterility of the drug products manufactured at this facility.

## Related Documents

- [483 - 2017-03-08](https://www.keypedia.com/records/483/puget-sound-drug-corporation-dba-key-pharmacy-and-compounding-center/b5fc1694-7808-4d67-bb58-d1db90843101)
- [483 - 2019-06-13](https://www.keypedia.com/records/483/puget-sound-drug-corporation-dba-key-pharmacy-and-compounding-center/b2707b2d-4c29-4602-bafc-96fff5c664e6)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)
- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/puget-sound-drug-corporation-dba-key-pharmacy-and-compounding-center/427808bb-24a0-4bb9-98b5-5e97ce9344dc

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913