1Laboratory and QC controls
Laboratory contlols do not include the estab1ishmetJt of ·"-~'·'""'"''".,.
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
2Training and personnel
Clothing ofperSonnel engaged in t.he processing ofdrug roducts is not appropriate for 11')e duties they perform.
3Equipment and facility
Equipment and utensils ace not c leaned at appropriate st1e ngth, quality or purity ofthe drug product.
4Labeling and packaging
The labels of your outsourcing facility's drug Jl)fCiouc l:s do not include information required by section S03B(a)(10)(A).
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient tegatding the for monitoring environmental cooditions.
6Equipment and facility
OB 014 Ste c OUt Wrltte.n p rocedures art not established for the cleaning maintenance of eq11ipm ent, includi11,g utensils, used l1l me manufactute, processing, packing or holding of a drug nTd!.dtu~t A .
7Aseptic processing and sterility assurance
Eacb batch ofdntg product porporting to be sterile and OY.t()stelt-th;e is not laboratory tested to determine confounance to such requirements .
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological cor~ta11ni~;atic>n of d~ products pwporting to be sterile are not estabHshed and followed.
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.
