1Material and supplier control
Representative samples are not taken ofeach shipment of each lot ofcomponents, drug product containers, and closures for testing or examination.
Inspection Record
American Family Pharmacy, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
3Material and supplier control
Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, and approval of components, drug product containers, and closures.
4Stability and storage
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
5Laboratory 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.
6Equipment and facility
Records are not kept for the maintenance, cleaning, and inspection of equipment.
7Process validation
Control procedures are not established which monitor the output and validate the perfonnance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
8Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
9Material and supplier control
were also observed to have no specifications regarding the approval and release oflabeling materials including container labels and cartons.
10Complaint and recall handling
Complaint records are deficient in that they do not include the findings ofthe investigation and follow-up .
11Training and personnel
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
12Laboratory and QC controls
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot withi n each shipment of components, drug product containers, closures, in-process materials, labeling, and drug products used in the manufacture, processing, packing, or holding of drug products .
13Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
14Material and supplier control
Procedures designed to assure that correct labels, labeling, and packaging materials are used tor drug products are not written and followed.
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.
