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An FDA inspection of Nostrum Laboratories’ Lenexa, Kansas facility found that it failed to properly identify and track bottles containing low pill counts after the company received complaints earlier in the year. Read More
An FDA inspection of Merck’s Durham, N.C., plant revealed lapses of good manufacturing practices for equipment and building maintenance, as well as problems with process controls and records. Read More
An FDA inspection of an over-the-counter drug manufacturing facility in Torrance, Calif., found failures to follow written cleaning and maintenance procedures as well as recordkeeping and testing lapses. Read More
Diamond Wipes International, a manufacturer of medicated wipes, drew a Form 483 with six observations following an FDA inspection at its Chino, Calif., manufacturing facility. Read More
An FDA inspection of Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing plant in Middleburgh, New York earlier this year found lapses in good manufacturing practice (GMP). Read More
Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. Read More
Over-the-counter drugmaker Sanit Technologies, which does business as Durisan, drew the FDA’s attention for water quality and other deficiencies observed during a March 1-5 inspection of its plant in Sarasota, Florida. Read More
The FDA issued a warning letter to generic drugmaker Lupin for good manufacturing practice (GMP) violations observed during an inspection of its plant in Somerset, New Jersey. Read More
Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. Read More
An FDA inspection of Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing plant in Middleburgh, New York earlier this year found lapses in good manufacturing practice (GMP). Read More