1Training and personnel
A training video using smoke to demonstrate air flow pattern in ISO 5 working areas under a static
Inspection Record
Custom Compounding Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The firm makes all of their high-risk level sterile solutions subjected to REDACTION (b)( 4) sterilization w ithout using any REDACTION (b)(4) prece ding or during filling into their final containers to remove particulate matter.
3Aseptic processing and sterility assurance
The firm does not assure on each of lot of biological indicators (BI's) received and used to determine the effectiveness of REDACTION (b)(4) ster ilization cycles.
4Aseptic processing and sterility assurance
The firm allows employees to enter ISO 5 areas wearing street clothes Underneath a non-sterile g own with exposed facial areas such as cheeks, eye brows, eye lashes, and forehead while performing aseptic fillin g of drug products.
5Aseptic processing and sterility assurance
The firm does not conduct sterility and endotoxin testing at the end of drug products' shelf lives in accordance with its procedure # PH103, date 07/09/09 titled "Clinical Policies & Procedures Beyond Use Dating/
6Other quality system
the firm did not review, approved, reject, or comment on whether bacterial and fungal air results from viable air monitoring conducted by an independent company against USP <797> standards is acceptable or not.
7Other quality system
The firm does not conduct inhibitory/enhancement testing on all of their products to see if their products interfere with endotoxin testing.
8Environmental monitoring
The firm does not perform environmental monitoring during filling (aseptically ftll after REDACTION (b)(4) such as viable and non-viable monitoring.
9Other quality system
There was an accumulation of dust in the return vents underneath the table of ISO 5 observed du ring environmental sampling performed on 11/ 15/12.
10Other quality system
The firm does not conduct growth promotion testing on purchased media.
11Other quality system
The firm has not verified/certified that the purchased REDACTION (b)(4) are a bl e to retain at least 10 to the 7th microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta on each square centimeter of final filter prior to filling into finished product vials.
12Other quality system
The firm does not use additives (i.e.
13Aseptic processing and sterility assurance
the firm does not test for pyrogen for their closures (i.e.
14Documentation and records
The following sterile injectable drug products were rejected and destroyed along with their batch r ecords for falling sterility and fungal testing or having questionable results without conducting any investigation in cluding determination of root cause or potential impact on other products.
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.
