Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Investigations into environmental monitoring excursions are inadequate and/or inappropriate Environmental Notices (EN) are the investigations that take place when tbe firm experiences either alert or action limits for p ersonnel, active air, and surface monitoring.
Operators working in the filling suites monitor their own gloves and garments after working in the area.
The firm's change control program is not followed.
Actions taken regarding non-viable particulate excursions that occur during aseptic filling on RED ACTION (b)(4) are inadequate.
Stoppers used with allergenic extract R EDACTION (b)(4) glycerin) final product vials have not been demonst rated to be non reactive, additive, or absorptive.
Growth promotion testing for environmental monitoring plates is not performed in a manner to chal leng e the test plate in that the firm's SOP for growth promotion testing allows for incubation of plates for up to REDACTION (b)(4)
Non-viable particulate excursion alanns are not reacted to in real time.
Product impact is not adequately addressed for incidences where contamination occurs on product contact services.
Since 11/15/12 the firm has experienced sterility failures for 9 commercial products .
The investigation conducted under PACAR PAC-021-081312 did not include a product impact assessment.
Smoke studies performed on Line REDACTION (b)(4) in Building REDACTION (b)(4) revealed the following: A.
The firm's supplier ofanimals which are used for the general safety testing of allergenic extracts has not been
SOP QC-033.00, Facility Bioburden, section 9.1.3 requires that "All environmental isolates are sent out for identification, including alert and action level samples, routine bioburden samples, media fill samples and Class 100 samples, shall be identified to the species-level".
The firm's routine process to REDACTION (b)(4).
No limits have been established for the amount of time allergenic extracts may be exposed to ambient temperature during filling, inspection, labeling and packaging, packing for shipping.
SOP MFG-031.01 "Cleaning Procedure for Vial Production Areas" does not contain sufficient detail e xplaining how filling equipment is to be cleaned.
There is a lack of assurance in the environmental quality in Class 100 aseptic processing areas in that the fir m does not perform adequate environmental monitoring within these areas .
The 100% visual inspection of REDACTION (b)(4) products filled on Line REDACTION (b)(4) is performed prior to REDACTION (b)(4) Only a cursory inspecti on of the units during REDACTION (b)(4) packaging is performed post REDACTION (b)(4) and labeling .
Aseptic processing deficiencies include: A.
The following facility and equipment maintenance issues were observed: A.
The number of qualified personnel is inadequate to supervise the manufacture of Allergenic Extract produc ts.Personnel engaged in manufacture of allergenic products have no definitive assigned supervisor.
The firm's procedures allow the release of allergenic extracts exhibiting cloudiness.
There is a Jack of assurance that limits set in the aseptic processing area are adequate.
Driving the labeling of Phenylephrine HCI injection Lot 042413 the vials after inspection and labeling were observed traveling down a REDAC TION (b)(4) from the REDACTION (b)(4) and t hen dropping into a bin.
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.
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