Inspection Record

Zhejiang Huahai Pharmaceutical Co. Ltd. — FDA 483 Findings

US FDAInspected 2016-11-18Published 2018-08-09 4 findingsAseptic processing and sterility assuranceEquipment and facilityOther quality systemLaboratory and QC controls

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Written procedures designed to prevent contamination ofdrug products purporting to be sterile are not followed.

2Equipment and facility

Processing areas are deficient regarding the system for cleaning and disinfecting the equipment.

3Other quality system

Data is not recorded contemporaneously.

4Laboratory and QC controls

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.

About this record

Extracted automatically from the document US FDA published on 2018-08-09. 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.

Translation and classification are automated and may differ in nuance from the source.

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Zhejiang Huahai Pharmaceutical Co. Ltd. findings history — including this company's other documents US FDA documents, 2018 Go to Findings search