Inspection Record

Apollo Care LLC — FDA 483 Findings

US FDAInspected 2018-10-24Published 2024-01-17 3 findingsMaterial and supplier controlDocumentation and recordsLabeling and packaging

Inspectors Michele Perry-WilliamsThe inspectors who signed the published document.Inspector lookup

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

Findings

1Material and supplier control

Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

2Documentation and records

Batch production and control records do not include results of examinations made of packaged and labeled products for correct labeling.

3Labeling and packaging

The labels of your outsourcing facility's drug products are deficient.

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

2026-04-21 · US FDA · 13 findings2025-03-27 · US FDA · 5 findings2023-04-05 · US FDA · 3 findings2021-09-08 · US FDA · 3 findings
Apollo Care LLC company profile — full history US FDA documents, 2024 Go to Findings search