Inspection Record

Stokes Healthcare Inc. — FDA 483 Findings

US FDAInspected 2018-10-24Published 2024-01-17 3 findingsLabeling and packagingDocumentation and recordsStability and storage

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

Findings

1Labeling and packaging

The labels of some of your outsourcing facility's drug products do not include information required by section 503B(a)(l O)(A) and (B).

2Documentation and records

Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.

3Stability and storage

Results of stability testing are not used in determining expiration dates.

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

2023-10-25 · US FDA · 9 findings
Stokes Healthcare Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search