1Other quality system
response: Advanced Care Infusion will review and further proceduralize the processes for cleaning ofthe ISO 5 laminar flow hoods, as well as the buffer room and ante room.
Inspection Record
Tri-Med, Inc. dba Advanced Care Infusion-Shelby — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
For each ofthe discrepancies and out-of-specification results below, there was inadequate investigation in that no immediate remediation and/or appropriate corrective actions were taken to address the issue.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Other quality system
response: Advanced Care Infusion is a pharmacy that prepares doses pursuant to a valid prescription for an individual patient.
5Other quality system
response: Advanced Care Infusion will research upgrades to the environment which may be implemented to achieve greater compliance with USP <797> standards with regard to design of ISO 7 environment.
6Other quality system
response above), Advanced Care Infusion policy meets USP <797> guidelines, which recommend that certification procedures shall be performed "no less than every 6 months".
7Aseptic processing and sterility assurance
The cleaning and sanitization activities performed in the aseptic processing areas are not adequate.
8Equipment and facility
response: Advanced Care Infusion has demonstrated that the air supply in our classified environments is filtered through HEP A filters, and also provides positive pressure differential.
9Other quality system
Observation 2A, and Observations 1 and 4A through 4F, above, which have previously addressed Advanced Care Infusion's response and plan of action for items i., ii., and iii., respectively.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high efficiency particulate air filters under positive pressure.
11Other quality system
response: We believe that Advanced Care Infusion did in fact take corrective action in response to this issue.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that the floors, walls, and ceilings do not consist ofsmooth surfaces that are easily cleanable.
13Aseptic processing and sterility assurance
The majority of procedures governing aseptic processing operations at your facility are either not written, inadequate, or not followed.
14Other quality system
No potency testing is performed for any of the drug products produced.
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.
