1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma — FDA 483 Findings
Inspectors Russell K. Riley · Lisa T. Michel · Gary C. PecicThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
4Material and supplier control
Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
5Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
6Equipment and facility
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Aseptic processing and sterility assurance
4625 N Uni versity St Producer of sterile drugs The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
9Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
10Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
13Aseptic processing and sterility assurance
Drug product containers were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
14Quality unit oversight
Approved components and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
15Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
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.
