1Contamination control
There is no data to support that the firm's processing procedures will not increase the risk of cross contamination between products.
Inspection Record
Central Admixture Pharmacy Services, Inc. (CAPS) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
In 2007, the firm had a large walk in refrigerator installed in the warehouse.
3Other quality system
The firm manufactures admixtures from commercially available finished products.
4Aseptic processing and sterility assurance
The environmental monitoring and conditions ofthe aseptic core are deficient for the following reasons.: a.
5Aseptic processing and sterility assurance
The firm applies expiration dating to all compounded sterile injectable products.
6Other quality system
The firm uses wet lines for their sprinkler system.
7Other quality system
The loading door in the warehouse is approximately 8 feet by 8 feet 2 inches.
8Equipment and facility
Differential pressure is not adequately monitored and controlled between in the controlled manufacturing areas.
9Aseptic processing and sterility assurance
Air Flow pattern studies "smoke studies" are inadequate for the following reasons: a.
10Aseptic processing and sterility assurance
T here is a lack of microbial reduction/control steps in the manufacturing process of sterile drug products.
11Other quality system
T he following events were inadequately investigated, root cause was not determined and pe rmanent corrective actions not implemented: a.
12Aseptic processing and sterility assurance
The following poor aseptic technique was observed for manufacturing personnel during gowning operations before entering the controlled manufacturing areas: a.
13Aseptic processing and sterility assurance
The sterile technique qualification (media fills) do not represent your routine operating conditions and does not evaluate worst-case activities that can provide a challenge to manual aseptic operations.
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.
