1Training and personnel
Lack of adequate personnel sampling.
Inspection Record
First Royal Care Co. LLC, dba Red Mountain Compounding — FDA 483 Findings
Inspectors Christopher M. JennerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
3Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
4Other quality system
Routine checking of scales used for production is not performed to assure proper performance.
5Laboratory and QC controls
(Repeat Observation) 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.
6Aseptic processing and sterility assurance
The cycle parameters (temperature, pressure and time) used for <Redacted B4> of product intended to be sterile are not lethal to heat-resistant microorganisms.
7Other quality system
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.
8Stability and storage
(Repeat Observation) There is no written testing program designed to assess the stability characteristics of drug products.
9Aseptic processing and sterility assurance
The <Redacted B4> intended to render final product sterile was not pharmaceutical grade.
10Aseptic processing and sterility assurance
(Repeat Observation) Sporicidal agents were not adequately used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
11Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
12Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gown components.
13Aseptic processing and sterility assurance
(Repeat Observation) Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
14Environmental monitoring
Lack of adequate routine environmental monitoring.
15Other quality system
<Redacted B4> testing to the <Redacted B4> was not performed.
About this record
Extracted automatically from the document US FDA published on 2021-10-28. 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.
