Inspection Record

Shertech Pharmacy — FDA 483 Findings

US FDAInspected 2019-07-02Published 2019-09-16 8 findingsProcess validationMaterial and supplier controlEnvironmental monitoringAseptic processing and sterility assuranceLaboratory and QC controlsStability and storage

Inspectors Jared P StevensThe inspectors who signed the published document.Inspector lookup

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

Findings

1Process validation

There are no written procedures for production and process controls designed to assume that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

2Material and supplier control

Records associated with drug product components, containers, closures, labeling, production, control and distribution and within the retention period for such records, were not made readily available for authorized inspection.

3Environmental monitoring

Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseplic processing area.

4Aseptic processing and sterility assurance

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

5Material and supplier control

Each component is not tested for conformity with all appropriate written specilicati.o.ns for purity, strength, and quality.

6Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and streagtb of each active ingredient prior to release.

7Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

8Aseptic processing and sterility assurance

Personnel engaged in aseptic processing were observed wearing non-sterile gloves.

About this record

Extracted automatically from the document US FDA published on 2019-09-16. 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.

Other records for this company

2019-07-18 · US FDA · 4 findings
Shertech Pharmacy findings history — including this company's other documents US FDA documents, 2019 Go to Findings search