FDA Investigators Clarify Common Concerns With Draft Inspection Guidance
FDA draft guidance on what constitutes delaying or denying an inspection continues to leave drugmakers concerned about how to interact with agency investigators on issues such as photos and records retrieval.
A group of investigators from the FDA’s Baltimore district offered their insights and best practices on how to address those issues during a roundtable at FDAnews’ Inspections Summit, which ran Oct. 23-25 in Bethesda, Md.
One key topic discussed at the summit was whether it would be considered limiting an inspection if an investigator is not given access to necessary documents for an “unreasonable period of time.” Drugmakers commented that the draft guidance provides no explanation on what is “unreasonable” in that regard.
It turns out that the answer is 24 to 36 hours, at least for investigators at the FDA’s Baltimore district.
“If you have a problem getting a record, explain it to your investigator,” said investigator Lori Lawless.
Lawless said she would understand if records are stored two time zones away and will take 24 to 36 hours to get. “Are we going to be happy about it? No, there is nothing I can do, but at least you can get me the records,” she said.
If after 36 hours there are still no records then that is a problem, Lawless said.
If the records are on-site then they shouldn’t take 24 hours to obtain, said Rachel Harrington, drug specialist for the FDA. She said she would be lenient if the records were off-site, but the company should give her something else to look at which is more accessible, such as standard operating procedures.
Lawless added that the agency doesn’t take a company’s original records. If an investigator is insistent on taking the originals, the company should call the district office, she said.
Another controversial part of the guidance focused on the thorny issue of taking photographs during an inspection. The guidance asserts that refusing to allow photos could lead to a company’s products being deemed adulterated.
The issue is actually cut-and-dry for the investigators at the summit. “We don’t take pictures for frivolous purposes,” Lawless said. “We take pictures as evidence to document an objectionable observation. We don’t just take random pictures of equipment.”
Harrington gave an example of a recent inspection, in which she noticed a large, black splatter on a HEPA filter. She said that she asked if she could take a photo of the splatter, since it would be easier to have a picture of it than describe it in words.
Lawless said that investigators are aware of the policies that a company has in place regarding photos. “We give you the option of taking a picture with us,” she said.
She said she has experienced some pushback, but it is “not an argument we like to have.”
Investigators also offered up some useful best practices and tips for what to do during and after an inspection, including:
Copy original records onto differently colored sheets of paper to more easily identify which records are the originals and which are for the agency;
After an inspection closes, a company can expect to receive a Form 483 within 45 days, but sometimes a district can get backlogged. If a company doesn’t have an establishment inspection report within two to three months, call and ask the district what happened;
Investigators have no problem with an open corrective and preventative action (CAPA) report. However, the company must demonstrate it is still working on implementing that CAPA; and
Don’t be afraid of performing an honest internal audit, because investigators can’t look at a company’s internal audit report. “That is because we want you to do those internal audits and be open and honest and not be afraid that if you put something in there it will be held against you,” said Harrington.
You may have been in this situation — perhaps you voiced an opinion about photos during an FDA inspection. But what is required of you during an inspection? Are you certain? Investigations Operations Manual 2013 will clarify that and more, so order your copy.