FDA Noted Serious Issues at Specialty Compounding during March Inspection
The company tied to a string of blood stream infections in Corpus Christi patients receiving calcium gluconate infusions was recently issued a FDA Form 483 after a mid-March inspection of their facilities near Austin, Texas.
So far, atleat 15 reports of bacterial infections caused by Rhodococcus equi have been recieved by the FDA relation to Specialty Compounding leading to a nationwide recall.
Specialty Compounding Issued FDA Form 483
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.” – FDA Form 483
- According to the FDA Form 483, investigators cited eight observations that could be seen as conditions violating the Food Drug and Cosmetic Act.
- The first observation cited that pharmacists in the facility are not following proper procedures to ensure sterility. This included pharmacist wiping exposed areas of the skin without changing gloves before continuing work and a pharmacist crawling on the floor to retrieve a vial without re-gowning or changing gloves before handling components like vials, syringes, and IV bags.
- Observations included reports of the facility lacking proper validation of sterilization procedures and processes.
- Another observation stated that products required to be free of objectionable microorganisms are not tested through appropriate laboratory testing. Specifically, the company was not conducting routine sterility testing for all of their injectable drugs.
- The final observation stated the aseptic processing areas were “deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.”
The Issuing and Consequences of a FDA Form 483
- The Food and Drug Administration states a FDA Form 483 is issued after inspections in which an investigator has observed conditions that may constitute a violation of the Food Drug and Cosmetic Act.
- When a FDA Form 483 is issued, inspectors discuss their observations with a company’s senior management who must then respond in writing with a corrective action plan.
- While the FDA Form 483 itself does not constitute immediate actions, it is considered along with Establishment Inspection Reports, company responses, and evidence collected on site when in determining if further action is necessary.
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