Inspection Record

Absolute Veterinary Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2018-03-01Published 2024-01-17 5 findingsDeviation, CAPA, and investigationContamination controlAseptic processing and sterility assuranceOther quality system

Inspectors Patty P KaewussdangkulThe inspectors who signed the published document.Inspector lookup

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Findings

1Deviation, CAPA, and investigation

Your firm failed to conduct and document investigations of potency failures for the following compounded preparations that did not meet set potency specifications: • Buserelin Acetate 1mg/ml, Lot #LHRH052016 had potency results of 122.7%.

2Contamination control

Protective apparel is not worn as necessary to protect drug products from contamination.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

4Aseptic processing and sterility assurance

Drug product were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

5Other quality system

Your firm's products are intended to prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act.

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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