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# 7 Observations in Med Shop Total Care FDA-483
- URL: https://www.fdaweb.com/7-observations-in-med-shop-total-care-fda-483/
- Published: 2022-01-12T12:00:00.000Z
- Updated: 2026-09-14T17:28:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150916

FDA has released the FDA-483 issued following a 7/7-7/27/21 inspection at Med Shop Total Care, a Longview, TX, producer of sterile and non-sterile drugs. The specific [observations](https://www.fda.gov/media/155224/download?ref=fdaweb.com) were: 

- failing to make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production;
- the facility design allowed the influx of poor quality air into a higher classified area;
- non-microbial contamination was observed in the production area;
- disinfectant contact time (dwell time) and coverage of the item being disinfected were insufficient to achieve adequate disinfection levels;
- personnel touched equipment or other surfaces outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves;
- 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
- the firm released drug product in which the strength differed from, or its purity or quality fell below, that which it purports or is represented to possess.