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# Maitland Labs FDA-483
- URL: https://www.fdaweb.com/maitland-labs-fda-483/
- Published: 2020-03-11T12:00:00.000Z
- Updated: 2026-09-14T16:06:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146298

FDA has released the FDA-483 issued following a 2/19-2/28 inspection at Maitland Labs of Central Florida, an Orlando, FL, 503B outsourcing facility. The seven inspection observations were: 

- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
- failing to have a written testing program designed to assess drug product stability characteristics;
- aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
- failing to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance to such requirements;
- labels of the outsourcing facility’s drug products are deficient; and
- container labels of the outsourcing facility’s drug products are deficient.