Inspection Record

NECC — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 4 findingsAseptic processing and sterility assuranceValidation and qualificationDocumentation and records

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Findings

1Aseptic processing and sterility assurance

Betamethasone Repository Injection (Betamethasone Acetate and Betamethasone Sodium Phosphate Suspension 6 mg/ml), a product which is intended to be sterile, is sampled for sterility and endotoxin testing immediately after sterilization of the bulk compounded product in a REDACTED (B) (4) beaker.

2Validation and qualification

The firm's validation of the autoclave cycle does not take into account the fact that the autoclaved bulk product is not transfilled into a final container/closure system (vials) for a period of up to one week.

3Aseptic processing and sterility assurance

The samples taken immediately after completion of the autoclave sterilization cycle REDACTED (B) (4) are not representative of product that remains in the original REDACTED (B) (4) beaker for up to one week past the time of sampling.

4Documentation and records

On at least one occasion, a lot number (Lot 02 01 2002@027) was generated in the firm's computerized record keeping system, for which no associated records could be retrieved.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

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