Inspection Record

Coast Quality Pharmacy LLC — FDA 483 Findings

US FDAInspected 2018-06-11Published 2024-01-17 13 findingsAseptic processing and sterility assuranceLaboratory and QC controlsMaterial and supplier controlTraining and personnelDeviation, CAPA, and investigation

Inspectors Joanne E King · Jennifer L Huntington · Christie A SotoThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

The ISO 5 classified aseptic processing ai·eas and segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

3Laboratory and QC controls

The written stability program for drug products does not include reliable, meaningful and specific test methods.

4Aseptic processing and sterility assurance

You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.

5Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

6Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

7Training and personnel

Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.

8Aseptic processing and sterility assurance

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

9Deviation, CAPA, and investigation

Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.

10Aseptic processing and sterility assurance

Personnel moved rapidly in the vicinity of open sterile units and instruments which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.

11Aseptic processing and sterility assurance

Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.

12Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

13Material and supplier control

Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures.

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.

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

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