Inspections News

Inspections News

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ARTICLES

Device

Infections from Implanted Devices Earn Stimwave a 483

FDA investigators found Stimwave Technologies’ complaint handling procedures and corrective and preventive actions for its implantable pain treatment devices were not up to par, during a Jan. 29-Feb. 15 inspection of the firm’s Pompano Beach, Fla. Facility. Read More
Drug

FDA Warns Chinese API Supplier for Deficient COAs, Quality

The FDA issued a warning letter to an active pharmaceutical ingredient distributor in Chongqing southwestern China for serious problems with quality and certificates of analyses (COAs). Read More
Drug

Woodcock Raps Outsourcer for Failing to Report AERs

An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency. Read More
Device

FDA Questions Health-Chem’s Testing and Personnel Knowledge

Management at Health-Chem Acquisitions failed to ensure that every functional area responsible for the design and manufacturing of hCG test strips was properly resourced for achieving quality and compliance function, the FDA said following a Jan. 17-Feb. 20 inspection of the company’s Pompano Beach, Florida plant. Read More
Device

Validation, Qualification Problems Plague Dharma Research

Dharma Research failed to validate its processes or to qualify equipment used for its dental gel, the FDA said following a March 6-18 inspection of the firm’s Miami, Florida facility. Read More
Drug

Japanese Drugmaker Rapped for Cleaning Violations

The FDA hit API drugmaker Alps Pharmaceutical of Gifu, Japan with a Form 483 for contamination, inadequate written procedures for cleaning and other violations. Read More
Drug

Chinese OTC Firm Warned for Falling Short on Testing

The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release. Read More
Device

Bio-Med Lax on Control Procedures

Lax change control procedures and document control issues were uncovered during an April 16-19 FDA inspection of Bio-Med Diagnostics’ White City, Oregon facility. Read More
Device

Complaint Procedures Lacking at Pfizer Subsidiary

Failure to establish procedures for receiving, reviewing and evaluating complaints as well as failure to report complaints and other quality management issues landed Pfizer subsidiary PF Consumer Healthcare a 10-observation, 17-page FDA form 483 following a Feb. 25 to April 4 inspection of its manufacturing plant in Atlanta, Georgia. Read More
Drug

French API Maker Written Up for Quality Unit Failures

The FDA hit a French manufacturer of APIs and intermediates with a Form 483 for quality violations at its facility in Limay, west of Paris. Read More