1Aseptic processing and sterility assurance
Proccdurcs designed to prevaIt mic:robiologic:al COIdaIIIin.aioD ofdrug products purportjDg to be sterile do DOt include validation oftbe sterilizatioo process.
Inspection Record
H & P Industries, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Reprocessing was performed without the review oftile quality control unit.
3Aseptic processing and sterility assurance
we will assure that the post- sterilization specification is appropriate for this product As discussed with the Investigators, viscosity is a characteristic of this product which is influenced by user perception and preference.
4Other quality system
was exhaustively discussed with the Investigators over the course of the inspection.
5Deviation, CAPA, and investigation
Deviations from writtm spccificIItious .-e DOt justi1icd.
6Other quality system
Written procedures are not drded, RViewed aod IPIJIOwd by 1bo Ippiopiillltc orpnipficml UIIiIs.
7Other quality system
eagagcd in the manufactUre and packing of.
8Other quality system
Results of ~ testiDg II'C not used in determining expindion dates.
9Other quality system
Written MDR procedures have not been developed and implemented.
10Other quality system
There are DO written procccbRs for prodDctioo IOd prcx:ca coaarols deaiped to asswe tbIt abc drug products bave the ideatity, stn:Ingth, quality, Imd pmity they purport or In .epeaeated to poISOIII.
11Process validation
written producbon ucl process control procedures IIl'O DOt followed in 1be exccudoo ofproductioa IDd process cootrol fuoctious.
12Other quality system
Specifically: • Tri..I Plus BZK Prep Pads have a BZK.
13Other quality system
Proc:cdures cbigaod to preveot microbiological mnam"""ion ofdrug produds ....portiag to be Aerile are DOt foIlowN.
14Other quality system
lnvcstiptioos ofa faihR ofa betdl or my ofits c:omponeuts to meet any of its spccificIIIioas did not cxtaId to oCher batches oftbe same drug product.
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.
