Drug factory · FDA FEI 3002807757

Novocol Pharmaceutical of Canada, Inc.

25 Wolseley Crt, Cambridge, Canada

Problems found, fixed voluntarily at FDA's last inspection, May 3, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

11 drug inspections on record since 2010: 2 with no problems, 9 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Abaloparatide	Makes it	Radius Health, Inc.	70539-001
Articaine and Epinephrine	Makes it	Benco Dental, Dentsply Pharmaceutical Inc., Henry Schein, Inc., NDC, Inc., Novocol Pharmaceutical of Canada, Inc., Patterson Dental Supply, Inc., Septodont, Inc.	66975-417, 66975-418, 66312-601 +17
Bupivacaine and Epinephrine	Makes it	Septodont, Inc.	0362-0557, 0362-9011
Dyclonine	Makes it	Septodont, Inc.	0362-3971
Epinephrine and Lidocaine	Makes it	Benco Dental, Darby Dental Supply, LLC, Dentsply Pharmaceutical Inc., Henry Schein, Inc., NDC, Inc., Novocol Pharmaceutical of Canada, Inc., Patterson Dental Supply, Inc., Safco Dental Supply Co., Septodont, Inc., The Atlanta Dental Supply Company DBA Advanced Dental Products	66975-415, 66975-425, 66467-9710 +16
Epinephrine and Prilocaine	Makes it	Dentsply Pharmaceutical Inc., Novocol Pharmaceutical of Canada, Inc.	66312-580, 51004-5801
Lidocaine	Makes it	Septodont, Inc.	0362-0221
Mepivacaine	Makes it	Benco Dental, Darby Dental Supply, LLC, Dentsply Pharmaceutical Inc., Henry Schein, Inc., NDC, Inc., Novocol Pharmaceutical of Canada, Inc., Patterson Dental Supply, Inc., Safco Dental Supply Co., Septodont, Inc.	66975-406, 66467-9760, 66312-441 +8
Phentolamine	Makes it	Septodont, Inc.	0362-0101
Prilocaine	Makes it	Dentsply Pharmaceutical Inc.	66312-630

Ended	Result	Program	Problems noted
May 3, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 30, 2020	No problems found	Bioresearch Monitoring	—
Jun 21, 2019	No problems found	Bioresearch Monitoring	—
Jun 18, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jul 26, 2017	Problems found, fixed voluntarily	Bioresearch Monitoring	1
May 16, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 11, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 11, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 20, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 22, 2010	Problems found, fixed voluntarily	Postmarket Surv. and Epidemiology	—
Oct 22, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Registered with FDA for: manufacture.