> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 10 Observations on First Pharma FDA-483
- URL: https://www.fdaweb.com/10-observations-on-first-pharma-fda-483/
- Published: 2019-08-27T12:00:00.000Z
- Updated: 2026-09-15T01:46:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144869

FDA has released the FDA-483 issued following a 5/31 and 6/3-6/7 inspection at First Pharma Associates, Spokane, WA, a producer of sterile and non-sterile drug products. The 10 inspection observations [were](https://www.fda.gov/media/130142/download?ref=fdaweb.com): 

- non-microbial contamination was observed in the production area;
- personnel were observed manually contacting the inner surface of the container or closure;
- hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination;
- ISO-5 classified areas were not certified under dynamic conditions;
- personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product;
- the facility is designed and/or operated in a way that permits poor flow of personnel or materials;
- the facility design was observed to allow the influx of lower quality air into a higher classified area;
- inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed;
- media fills were not performed that closely simulate aseptic production conditions incorporating, as appropriate, worst-case activities and conditions that provide for a challenge to aseptic operations; and
- ISO-classified areas have difficult to clear, particle-generating, or visibly dirty equipment or surfaces.