For this week’s guidance, Dr. D struggled over making the decision to write about the need to establish procedures, the importance of acceptance activities, or the joys associated with responding to Form 483 observations. The doctor was able to waltz through the FDA’s Warning Letter Database and find a warning letter that provided great examples of all three topics. However, for this week’s Devine Guidance (DG), the doctor decided to focus on responding to Form 483 observations. Over the years, Dr. D has pontificated, on multiple occasions, the importance of formulating an acceptable response to a Form 483 observation. Many of you readers have already had the pleasure of responding to inspectional observations. Some have had more than one opportunity to experience the joys of responding to Form 483 observations. A few of the readers have had the pleasure of being on the receiving end of a warning letter. Astute Chief Jailable Officers (CJOs) recognize the importance of providing the FDA with a complete response, including documented evidence of correction. Even better, most CJOs will do everything in their power to ensure their establishments remain in compliance with all applicable quality, regulatory and statutory requirements. Remember, the word compliance is not some neologism (look-it-up). Additionally, compliance is not just another buzzword to be taken lightly. Furthermore, and contrary to the popular beliefs of many, “There is no such thing as minimum compliance or maximum compliance, there is only compliance.” Enjoy!

Warning Letter – August 3, 2016

Folks: Receiving 11 Form 483 observations during an agency inspection is almost always going to end badly for the offending establishment. Sprinkle in eight responses coming from FDA beginning with: “We reviewed your firm’s response and conclude that it is not adequate”, and the awarding of a not-so-prestigious FDA Warning Letter will be in the offending establishment’s future. A CJO does not need to be clairvoyant to see this outcome. The following warning letter excerpt, extracted from a 2016 warning letter, is not necessarily unique to the establishment on the receiving end of the warning letter referenced in this week’s guidance. In fact, during the course of a year, this same type of agency response can be seen in many of the warning letters issued each year by FDA. On a positive note, this type of agency response can be prevented with a clear and concise response to each Form 483 observation received when our friends from the agency appear in an establishment’s lobby for a friendly cup of java and an inspection.

Warning Letter Excerpt

Observation Five (5) – Failure to establish and maintain procedures for acceptance activities, as required by 21 0CFR 820.80(a). For example, your firm does not have written procedures for receiving, in-process, and final acceptance activities. Additionally, your firm conducts pressure testing on compression socks as part of final acceptance. Pressure testing is conducted using different calf and thigh former girths than specified in the equipment manufacturer’s instructions. However, no justification is documented for this change to the test process.

We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create procedures and contact the equipment manufacturer (b)(4) in a manner not specified in the instructions. However, there is no indication your firm plans to evaluate the potential impact of inadequately documented acceptance activities for previously distributed devices.

21 CFR, Part 820.80(a) – Receiving, In-process, and Finished Device Acceptance

(a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.