Drugs

14 Observations on Houston Rx FDA-483

FDA has released the Form FDA-483 issued following an 8/20-8/28 inspection at Houston Rx, a Houston, TX, producer of sterile drugs. The 14 inspection observations were:

personnel performed aseptic manipulations with exposed hair or skin;
a pattern of frequent or acute pressure reversals was observed from areas of less clean air to areas of higher air cleanliness;
inadequate redacted testing on a redacted product used to sterilize drugs;
personnel were observed manually contacting the inner surface of a sterile container or closure and manually touching a sterile product contact surface;
microbial contamination was present in the ISO 5 area;
the facility is designed and/or operated in a way that permits poor flow of personnel or materials;
sterile drugs were exposed to lower than ISO 5 quality air;
failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most challenging, and stressful conditions;
use of ingredients not intended for pharmaceutical use in sterile drug production;
contamination was observed in areas adjacent to production areas;
use of cleaning and disinfecting agents that may leave residues or not adequately rinsing such agents from containers, closures, or equipment that comes into direct contact with drug products;
sterile products were exposed to non-sterile or non-depyrogenated supplies;
failure to use biological indicators to verify the adequacy of the sterilization cycle; and
failure to store active pharmaceutical ingredients per the labeled storage conditions.

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