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196 books found — Page 6 of 7
Major inspection looks at Biocraft dosage forms, BPCs.(Brief Article): An article from: Inspection Monitor
Major inspection looks at Biocraft dosage forms, BPCs.(Brie…
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Alcon, FDA spar over need to file IOL MDRs.(intraocular lenses inspection leads to disagreement over Medical Device Reporting): An article from: Inspection Monitor
Alcon, FDA spar over need to file IOL MDRs.(intraocular len…
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OTC drug records now available to inspectors : But will new FDA law change audits?(Brief Article): An article from: Inspection Monitor
OTC drug records now available to inspectors : But will new…
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Drug GMP violations lead plasma 483 items.(drug good manufacturing practice rules broken at plasma derivative companies)(Brief Article): An article from: Inspection Monitor
Drug GMP violations lead plasma 483 items.(drug good manufa…
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Second-hand water system headache for Piedmont.(Outsourcing Services Group)(Brief Article): An article from: Validation Times
Second-hand water system headache for Piedmont.(Outsourcing…
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IDEC, Medeva audits highlight bioburden, cleaning citations.(Medeva Pharma, IDEC Pharmaceuticals warned)(Brief Article): An article from: Validation Times
IDEC, Medeva audits highlight bioburden, cleaning citations…
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Agency cites Pharma Fab for inadequate sterilization procedures.(Human drugs): An article from: Validation Times
Agency cites Pharma Fab for inadequate sterilization proced…
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In-vivo bioavailability studies lack validity at MDS Pharma; contamination cited.: An article from: Validation Times
In-vivo bioavailability studies lack validity at MDS Pharma…
By: Evelyn Heitman
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FDA to pilot dispute resolution, giving 10 days to challenge 483s.: An article from: Inspection Monitor
FDA to pilot dispute resolution, giving 10 days to challeng…
By: Tamra Sami
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Purdue receives 483 for electronic issues, Part 11 compliance problems.(Food and Drug Administration investigates Purdue Pharma L.P.): An article from: Bioresearch Monitoring Alert
Purdue receives 483 for electronic issues, Part 11 complian…
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Calibration, temperature control snare blood center.(Adventist Health Walla Walla General Hospital)(Brief Article)(Company Profile): An article from: Validation Times
Calibration, temperature control snare blood center.(Advent…
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Broken bottle, glass contamination the focus of Amersham inspection. (Human drugs).: An article from: Validation Times
Broken bottle, glass contamination the focus of Amersham in…
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Packaging cited at Becton, Mercury hit on calibration.(Brief Article): An article from: Validation Times
Packaging cited at Becton, Mercury hit on calibration.(Brie…
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FDA snares 3 more OTC drug makers for GMP problems.(Opti-Med Controlled Release Labs)(Imperial Drug & Spice)(Wayzata Bay Products): An article from: Validation Times
FDA snares 3 more OTC drug makers for GMP problems.(Opti-Me…
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Broken bottle, glass contamination the focus of Amersham inspection. (Human Drugs).: An article from: Inspection Monitor
Broken bottle, glass contamination the focus of Amersham in…
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Uncertified anti-fungus oil, labeling sends OTC firm to clean up act. (Human drugs).: An article from: Validation Times
Uncertified anti-fungus oil, labeling sends OTC firm to cle…
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Small OTC drug maker gets hit with big 483 over lack of written SOPs. (Human Drugs).: An article from: Inspection Monitor
Small OTC drug maker gets hit with big 483 over lack of wri…
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OTC drug maker cited for failures in five 'systems,' plus uncalibrated scales. (Human drugs).(Grafor Manufacturing): An article from: Validation Times
OTC drug maker cited for failures in five 'systems,�…
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FDAer cuts language barrier to nail computer validation.(Pharmacia and Upjohn inspection)(Brief Article): An article from: Validation Times
FDAer cuts language barrier to nail computer validation.(Ph…
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Computer audits to be accessible from library : FDA backing PDA validation effort.(Parenteral Drug Association)(Brief Article): An article from: Inspection Monitor
Computer audits to be accessible from library : FDA backing…
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FDA admits not comparing drug GMPs in drafting supplement rules; some standards stiffer than for OTC drugs. (Supplements).: An article from: Validation Times
FDA admits not comparing drug GMPs in drafting supplement r…
By: Ken Reid
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Computer system problems result in slap for Torrance.(Brief Article): An article from: Validation Times
Computer system problems result in slap for Torrance.(Brief…
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Diet supplement GMPs may be stronger than for OTC drugs, attorney, FDA says.: An article from: Warning Letter Bulletin
Diet supplement GMPs may be stronger than for OTC drugs, at…
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Opti-Med, FDA debate stability and validation interpretations for OTCs. (Human Drugs).(over-the-counter drugs): An article from: Inspection Monitor
Opti-Med, FDA debate stability and validation interpretatio…
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Gensia Sicor, Medi-Physics and TMED hit on cleaning, sterility validation faults.: An article from: Validation Times
Gensia Sicor, Medi-Physics and TMED hit on cleaning, steril…
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Parts replacement and malfunctions seen being negated with good change SOPs. (Change control).(safety operating plans): An article from: Validation Times
Parts replacement and malfunctions seen being negated with …
By: Elisa Ludwig
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Lax calibration, MDR of chiropractic table pinned on Sweat.(Brief Article): An article from: Validation Times
Lax calibration, MDR of chiropractic table pinned on Sweat.…
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Overuse of resins in chromatography column cleaning, reliance on impurities tests not always advised.(by the Center for Biologics)(Brief Article): An article from: Validation Times
Overuse of resins in chromatography column cleaning, relian…
By: Amy Covington
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Warning letters.(Food and Drug Administration warning letters.): An article from: Bioresearch Monitoring Alert
Warning letters.(Food and Drug Administration warning lette…
By: Charles J. Winter
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CSF shunt maker must revalidate sterilization, 510(k) commitment cited.(cerebrospinal fluid )(Radionics): An article from: Validation Times
CSF shunt maker must revalidate sterilization, 510(k) commi…
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Plain-Jane GMPs litter 483, warning letter for X-ray firm.(Brief Article): An article from: Inspection Monitor
Plain-Jane GMPs litter 483, warning letter for X-ray firm.(…
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USP may do chapter on equivalency of micro methods; PDA 33 due by April. (Methods validation).: An article from: Validation Times
USP may do chapter on equivalency of micro methods; PDA 33 …
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