1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
BMD Skincare — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.
3Material and supplier control
There was a failure to handle and store components at all times in a manner to prevent contamination.
4Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10) (A).
5Documentation and records
Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.
6Other quality system
You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).
7Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
8Laboratory and QC controls
Samples taken of drug products for determination of conformance to written specifications are not representative.
9Quality unit oversight
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
10Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
