Inspections News

Device

Singapore Diagnostics Maker Fails to Establish SOPs for Investigations

Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Read More
Drug

FDA Warns Montana Compounder Over Insanitary Conditions

The FDA issued a warning letter to a Montana compounding pharmacy for insanitary conditions and significant violations of good manufacturing practices. Read More
Drug

FDA Hits Texas Drug Facility for Oversight of Pilot/Exhibit Batches

The FDA cited Sovereign Pharmaceuticals for quality and other failures observed during a Dec. 11-19 inspection of its facility in Fort Worth, Texas—including its failure to ensure the quality of pilot or exhibit batches. Read More
Device

FDA Finds Quality Lapses at Las Vegas Defibrillator Manufacturer

A litany of quality management lapses landed contract manufacturer Rechargeable Power Energy North America a warning letter following a Nov. 5-9, 2018 FDA inspection of its Las Vegas, Nevada facility. Read More
Device

FDA Warns Orchid Orthopedic for Documentation Failures

Failure to document re-worked nonconforming products and to establish procedures for controlling process parameters were just a few of the many quality system failures documented in a May 13 warning letter to devicemaker Orchid Orthopedic Solutions following a Feb. 4-15 inspection of its Holt, Michigan plant. Read More
Drug

Florida OTC Maker Warned for Testing and Quality Issues

The FDA hit Pompano Beach, Florida OTC drugmaker AMMD Labs with a warning letter for inadequate testing and other violations. Read More
Drug

Pennsylvania Drugmaker Cited for Stability Testing

The FDA hit a Levittown, Pennsylvania drug manufacturer with a Form 483 after an inspection turned up inadequate stability testing and other violations. Read More
Drug

Ex-FDA Investigator Blows Whistle on FDA’s Handling of Foreign Inspections

The FDA is struggling to keep inspections of facilities overseas up to par, according to a former agency investigator. Read More
Drug

FDA Warns North Carolina Firm for Unapproved, Misbranded Drugs

The FDA issued a warning to GoLean Detox US of Charlotte, North Carolina for marketing unapproved, misbranded and potentially dangerous drugs. Read More
Device

Surgisil Warned for Unapproved Marketing of Facial Implant

Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks. Read More