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Teva Pharmaceuticals was given a three-observation Form 483 following an inspection of its Fairfield, N.J., finished product manufacturing firm for inadequately cleaned and maintained equipment and other lapses. Read More
The FDA handed Defender SD Manufacturing a five-observation Form 483 following an inspection of its San Diego, Calif., facility for a quality unit that lacked authority to investigate errors, lack of written production procedures and environmental monitoring deficiencies, among other lapses. Read More
The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls for its drug products, and other lapses. Read More
Global Pharma Healthcare — the Chennai, India-based drugmaker that has issued two recent high-profile recalls of its eye drops for potential contamination — drew an 11-observation Form 483 from the FDA citing lax sterility practices and other deficiencies. Read More
The FDA dinged Dunagin Pharmaceuticals’ Rogers, Ark., drug manufacturing facility for its water system, its drug manufacturing and equipment cleaning processes, and for other deficiencies observed during an Aug. 29 to Sept. 2, 2022 inspection. Read More
Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production control as well as not having established an adequate quality control unit, among other serious lapses.
The FDA rapped German pharmaceutical company B. Braun Medical for failing to thoroughly review unexplained batch discrepancies, a quality control unit that lacks the authority over drug products, failure to follow production and process control procedures, and other lapses observed during an inspection of the company’s Daytona, Fla., plant. Read More
The FDA dinged generics maker Cipla’s quality unit for several lapses, including failing to properly investigate batch discrepancies or the impact of power outages on drug product, during a Feb. 6-17 inspection of the company’s Madhya, Pradesh, India plant. Read More
Cosmoceutical Research Center was hit with a five-observation Form 483 following an inspection of its Panorama City, Calif., facility for lack of written quality control procedures, failing to test incoming components and several other lapses. Read More
ALI Pharmaceutical, a drug intermediate and active pharmaceutical ingredient (API) manufacturer in Omaha, Neb., was hit with a Form 483 for microbial contamination of products, failure to establish microbiological specifications for finished products and other lapses. Read More
Baudette, Minn.-based Ani Pharmaceuticals was hit with a six-observation Form 483 from the FDA that spotlights almost a year of ignoring customer complaints about products and not following its standard operating procedures (SOPs) for handling events that set off alarms in production.