13-Observation 483 for Compounding Pharmacy


In a recently posted warning letter to a compounding pharmacy based on an 8-page 483 that contained 13-observation was issued following an inspection (June –July 2-16) where the FDA was responding to a reported adverse event involving Chloral Hydrate.

Examples of items identified during the FDA inspection and documented on the Form 483 include but are not limited to:

Observation 1 – there is no quality control unit.

The firm produced and distributed non-patient specific non-sterile oral liquid containing Chloral Hydrate 100mg/mL.  Review of the batch record identified the active ingredient was 10 times the amount required resulting in a super potent drug product.

The firm did not reject the drug, no potency testing is performed, and no samples were retained.

From the warning letter: FDA analysis showed that the chloral hydrate drug product contained in excess of 900% of the labeled concentration of chloral hydrate thus superpotent.

Observation 2 – The firm has not established or followed procedures to prevent microbial contamination of drug product.

Multiple issues with gowning, residue on equipment from prior processing, open trash recepticals in all of the firms classified areas, lack of validation for the autoclave for low configurations and capacities, no validation for the depyrogenation process, etc.

Observation 3 – Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

No monitoring of viable microbial contamination in the ISO-7 and ISO-5 areas during processing.  No particulate monitoring in either of these areas, no monitoring of personnel, or monitoring of differential pressures.

Observation 4 – Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

No sporicidal cleaning agents used in ISO 5 processing areas. Non Sterile wipes used to clean classified area.

Observation 8 – Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

No calibration records for thermometer used to monitor dehydrogenation temperatures, the thermometer / pressure gages used in the autoclave, scales used to weigh materials used for processing were not calibrated, (linearity, accuracy, and repeatability were not tested).

Please review the 483 for additional details in each of the summarized observations as well as the observations that were not summarized.  The FDA warning letter contains additional information and actions the firm has taken subsequent to the FDA inspection.