1Quality unit oversight
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity , strength , quality and purity of drug products.
Inspection Record
Carlton’s Dunwoody Pharmacy Corp — FDA 483 Findings
Inspectors Tamara J Henderson · Rachael L CookThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
3Laboratory 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 strength of each active ingredient prior to release.
4Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch .
5Equipment and facility
The calibration of instruments is not done at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits are not met.
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.
