Inspection Record

SCA Pharmaceuticals, LLC. — FDA 483 Findings

US FDAInspected 2018-10-24Published 2024-01-17 10 findingsAseptic processing and sterility assuranceLaboratory and QC controlsEquipment and facilityDeviation, CAPA, and investigationQuality unit oversight

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

Findings

1Aseptic processing and sterility assurance

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

2Laboratory and QC controls

The written stability program for drug product s does not include reliable and meaningful test met hods .

3Equipment and facility

Buildings used in the manufacturin g, processing, packing and holding of a drug product are no t maintained in a good state of repair.

4Aseptic processing and sterility assurance

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

5Laboratory and QC controls

Established test procedures are not followed.

6Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been alr eady distributed.

7Equipment and facility

Records are not kept for the maintenance and inspection of equipment.

8Quality unit oversight

Each lot of components, drug product containers and closures is not withheld from u se un til the lots has been sampled, test, examined, and released by the quality control unit.

9Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

10Laboratory and QC controls

Testing and release of drug product for distribution do not include inappropriate laboratory determinatio n of satisfactory conformance to the identity and st rength of each active ingredient prior to release.

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.

Other records for this company

2026-03-13 · US FDA · 3 findings2025-10-30 · US FDA · 3 findings2024-12-20 · US FDA · 7 findings2015-07-10 · US FDA · 7 findings2018-04-09 · US FDA · 8 findings2018-01-08 · US FDA · 6 findings
SCA Pharmaceuticals, LLC. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search