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# 10 Observations in Greenpark FDA-483
- URL: https://www.fdaweb.com/10-observations-in-greenpark-fda-483/
- Published: 2021-09-23T12:00:00.000Z
- Updated: 2026-09-14T17:15:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150208

FDA has released an FDA-483 issued following a 7/2-8/12 inspection at Prescription Labs Inc., Houston, TX, a producer of sterile and non-sterile drugs doing business as Greenpark. The 10 inspection observations were: 

- personnel engaged in aseptic processing were observed with exposed skin;
- the firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;
- failing to conduct post-use integrity testing on a redacted item used to sterilize products;
- no assurance that sterile drug products were processed and stored under ISO 5 quality air;
- ISO-5 classified areas were not certified under dynamic conditions;
- the facility design was observed to allow the influx of poor quality air into a higher classified area;
- hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination;
- the company did not appear to use biological indicators during redacted processes of finished drug products;
- media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations; and
- ISO-5 classified areas were not certified under dynamic conditions.