Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Your ISO 5/7/8 classified areas where sterile injectable drug products are produced are not adequately sanitized in that disinfectants are not REDACTION (b)(4) as per SOP 4.001 "Env ironmental Monitoring & Cont rol Procedures" and t he isinfectant solution REDACTION (b)(4) identified as your sporicidal agent has not been shown to have sporicidal activit y against all types ofbacterial spores.
Smoke studies were not conducted for the ISO 5 hoods ; they were only conducted in the ISO 7 cleanroom with R EDACTION (b)(4) present which is not representative of routine aseptic operations w ith REDACTION (b) (4) operators.
Your firm does not test finished drug pr oducts for prese rvative content/anti-microbial effectiveness of REDACTION (b)(4) a.
The sterility testing by R EDACTION (b)(4) which is used to test pre-filled Human Chorion ic Gonadotropin (HCG) syringes has not been validated to determine whether the HCG formulation is bacteriostatic or fungistati c.
Your firm lacks adequate controls for issuing labels, examining issued labels, and reconciliation of used labels to prevent mix-ups.
Your firm lacks an adequate control system for the RE DACTION (b)(4) sterilization of Testosterone cypionat e injectable in that there are no written proc edur es describing the REDACTION (b)(4) the REDAC TION (b)(4) has not been validated, and conduct of t he REDACTION (b)(4) is no t documented in the Log of Use, Maintenance and Cleaning (LUMAC) of the REDACTION (b) (4).
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Your firm does not test finished drug products for preservative content/anti-microbial effectiveness of REDACTION (b)(4)
The labels of your outsourcing facility's drug products do not include information required by section 503B(a) (10)(A).
Inspection of finished product vials for particulates is not conducted a gainst a contrasting background.
Your firm lacked written procedures for qualifying vendors of non-sterile c omponents used in the production of sterile drug products.
P ursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2 .
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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