Failure to resolve at least six of 10 observations from an earlier inspection resulted in another Form 483 in January for Theweb2u.com, maker of the Therapik insect bite and itch relief device. Read More

A Form 483 cites Cocoa Beach, Fla.-based Ward Photonics for continuing problems with investigation and evaluation of customer complaints for possible medical device report (MDR) requirements. Read More

Maiden Biosciences received a Form 483 for quality system lapses after the FDA inspected the company’s Gaithersburg, Md., facility in November 2022. Read More

FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More

The FDA handed Sea-Long Medical Systems a warning letter on April 4 for failing to notify the agency of expanded indications for its treatment hood device. Read More

Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of batches that ended up on the U.S. market and remained there without “adequate justification.” Read More

The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Read More

The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk drug substances. Read More

The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this and other issues raised in a recent inspection. Read More

Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Read More

Elkhart-Ind.-based Voyant Beauty, a division of Accra-Pac, received an FDA warning letter on April 20 for not appropriately addressing benzene contamination of its over-the-counter topical aerosol products, found during an Aug. 23-Sept. 2, 2022 inspection. Read More

Significantly modifying its Velopex Aquacut fluid abrasion unit in multiple ways without submitting a new 510(k) clearance application has resulted in the UK’s Medivance Instruments receiving a Feb. 13 warning letter from the FDA. Read More