OTC Manufacturer Warning Letter


Recently a manufacturer of an OTC product was inspected by FDA (Nov 2017) and the resultant warning letter was posted on the FDA website May 2018.  This firm received 3 citations which are summarized below:

Observation 1 – the firm elected to manufacture the OTC product with raw material that had not been tested and released by the quality unit.  The OTC firm’s response was that they would manufacture at risk and would take the appropriate actions should the raw material not meet its specification.  FDA’s response – “Your response is inadequate. It is unacceptable as a matter of CGMP to manufacture drugs from components that have not been tested or examined prior to use, and released for use by the quality unit.”  21 CFR 211.84(a) states: Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. – pretty straight forward.

Observation 2 – The OTC firm failed to follow their own procedures for cleaning equipment.  During the inspection the firm acknowledged the error.  However, as is often the case the firms response was not adequate in that they didn’t asses the impact on product quality, didn’t identify what corrections were put in place to prevent reoccurance. 21 CFR 211.67(b) requires SOPs to be established and followed.

Observation 3 – The firm did not have adequate records of major equipment maintenance, cleaning, and use.  The OTC firm uses a combination form to document cleaning but the forms do not document who did what and when.  When questioned on two specific entries the firm could not state if the documentation was for cleaning the mixer, the filler, or the room. As also identified multiple fields in the logs were blank.  21 CFR 211.182 has specificity concerning what must be included in the records.

Ultimately the FDA recommended a cGMP consultant be retained by the OTC firm to assist the firm in complying with cGMPs.

One simple suggestion might be for senior managment to do a Gemba Walk.  A term used to describe personal observation of work – where the work is happening.  If the FDA inspector can spot incomplete forms, failure to follow procedures being on site for often short periods, one would expect that the firms managment or internal audit team could also.

Have a question on cGMPs, FDA inspection methods or practices, or just what do I need to do when?  Contact Dr. Van Doel, or use our Contact Us form and one of PVs experts can respond to your question.