FDA 483 - Greer Laboratories, Inc. - November 15, 2013

The FDA Form 483 details numerous violations at a facility manufacturing allergenic extracts. The product is not manufactured as described in the approved license application, with custom compounded lots not linked to specific patients. Reserve samples are not retained for custom mixed lots or final formulated bulk lots. Unapproved reprocessing, such as decanting precipitated product, occurs without quality unit review.

The facility fails to perform required General Safety tests on numerous allergenic extract lots, including custom mixed, standardized, and non-standardized products, even when adverse events are reported. Laboratory controls lack scientifically sound specifications, and a drug product (Modified Glycerco Cocas lot # 216273) with "too numerous to count" bioburden was released without assurance of meeting validated limits. General Safety Test failures are inadequately investigated, and the impact of varying concentrations on test results is not validated.

Appearance of bulk extract and filled products is not documented, hindering detection of changes. Out-of-specification test results, particularly sterility failures, are invalidated without definitive laboratory error, leading to retesting and release of potentially contaminated lots. There is no assurance that required testing is performed on representative samples, especially for custom orders with multiple components.

Aseptic processing facilities are deficient, with no clear separation of activities to prevent mix-ups during formulation and filling. Reprocessing of product with visible particulates is not properly documented or simulated during media fills. Handwashing facilities are inconvenient, potentially contributing to contamination. Air monitoring