Drug factory · FDA FEI 3003690012

Clinical Medical Services Inc

Carr PR-3 KM 9.5 Ave 65 Infanteria Reparto Industrial San Gabriel, Carolina, PR, United States

Problems found, fixed voluntarily at FDA's last inspection, Nov 7, 2011.

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

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

What it does, for whom

Drug	Role	For	NDC
Oxygen	Makes it	Clinical Medical Services Inc.	67191-001, 67191-123

Ended	Result	Program	Problems noted
Nov 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.

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified.
Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
No written record of investigation 21 CFR 211.192
Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.

Registered with FDA for: manufacture.