COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. At this year's PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date. The Observations within the top ten usually do not change --- although their frequency may vary. Where a specific section is indicated, the Title indicates … [Read more...]
CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010
CDER NAMES THESE TEN (21 CFR 211) Comment The following represent those most frequent Observations that CDER posted for fiscal year 2010 based on a total of 646 FDA Form 483. REFERENCE             … [Read more...]
