Drug factory · FDA FEI 3008349307

Delpharm Tours

Rue Paul Langevin, Chambray-les-Tours, France

Problems found, fixed voluntarily at FDA's last inspection, Jun 11, 2021.

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

3 drug inspections on record since 2011: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Zinc Cation	Makes it	Laboratoire Aguettant	60710-001

Ended	Result	Program	Problems noted
Jun 11, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 13, 2016	No problems found	Drug Quality Assurance	—
Jul 7, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug product containers conform to appropriate standards of identity, strength, quality and purity.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: manufacture.