FDA inspections are a part of life for dietary supplement manufacturers, but regulations and procedures are not always clear. To help manufacturers better understand inspections, and to properly prepare for them, the American Herbal Products Association (AHPA) recently conducted a survey of FDA inspection documents.
AHPA requested FDA documents for inspections of any dietary supplement facility conducted between June 25, 2007, and July 31, 2010, for compliance with Title 21 of the Code of Federal Regulations, Part 111, which describes the requirements for cGMP (current good manufacturing practices) in manufacturing, packaging, labeling and holding operations. Since June 25, 2007, when FDA implemented Part 111, FDA has conducted periodic inspections of dietary supplement manufacturers, producing both Establishment Inspection Reports (EIRs) and Inspection Observation Forms (Form 483s).
In response to these requests, AHPA received 75 documents: 38 FDA Form 483s and 37 EIRs. Of these, 18 were duplicates, which left 57 unique inspection reports. Only observations concerned with dietary supplement manufacturing were considered. Looking at the entirety of the released reports, 14 out of the 57 documents, or 25 percent, reported their associated inspections had nothing observed by FDA, and no further actions were taken. The remainder of the documents had from one to 26 observations. In several cases, the inspection was of a dietary supplement and drug manufacturer, and some of the observations made by FDA did not concern any of the regulations in 21 CFR §111.
While a quarter of all FDA inspections were completed with no observations, half of FDA inspections had between two to seven distinct observations. In the inspections with observations, all subparts of 21 CFR §111 have appeared, but some parts are more frequently cited than others, and the most common observations are, in order of frequency:
- Subpart E: Production and Process Control System (PPCS) (Note: it’s common for an inspection to yield several rather than just one FDA observations under this subpart.)
- Subpart F: PPCS: Quality Control (Note: this subpart frequently produces only a single observation.)
- Subpart C: Physical Plant and Grounds
