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# Lachman Identifies 3 Big Industry Issues
- URL: https://www.fdaweb.com/lachman-identifies-3-big-industry-issues/
- Published: 2016-10-20T12:00:00.000Z
- Updated: 2026-09-14T21:41:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137134

Lachman Consultants says that three issues that drive drug companies crazy currently are **(1)** getting resolution of compliance status after inspection or re-inspection; **(2)** getting a straight answer from FDA; and **(3)** what to do about maximum daily exposure issues relative to the inactive ingredient database. “Most of the compliance issues we hear about are after a firm’s inspection or re-inspection where the investigator tells the firm that there are no issues or where there is no 483 issued,” the firm writes in a blog [post](http://www.lachmanconsultants.com/2016/10/what-is-driving-industry-crazy-lately/?ref=fdaweb.com). “According to some of our clients, approvals may be delayed because of this lag time.” The post says that it appears there is nothing a company can do to shake the final evaluation loose except wait.

The firm also reports instances in which a sponsor uses an online FDA form to submit a question, receives a reply that the question should be directed to a different answer line, does so, and then is told that the question should go to the first answer line approached. “There have also been instances where the cycle went full circle with three e-mails telling the sponsor that they needed to ask a different entity, closing the loop with referral back to the original e-mail recipient as the one that should answer the question,” it says.

Lachman says another scenario involves a sponsor with a question about a specific guidance or procedure. The question is phrased to outline the potential different interpretations for which the sponsor seeks clarification and either asks which interpretation is correct or asks for an explanation of something that is unclear. “In many instances, the response from the FDA office simply cites back to the specific section of the guidance without further clarification,” the post says. “Reference back to the guidance is not usually helpful without the extra step of making the requested clarification.” The consultants note that many agency answers respond adequately to the question asked, as long as the questioner has time to wait.

With regard to the inactive ingredient database, Lachman says that until the database is completely revised to include FDA’s listing of the maximum daily exposure for specific inactive ingredients in various dosage forms, drug sponsor formulation departments don’t know what to do. The issue is that the database information is only useful if a product’s maximum daily exposure is less than or equal to the amount listed in the database, if the listed amount is not listed as a maximum daily exposure. This is because, the post says, one cannot tell from the database what the product is or how it might be dosed, as many of the values only reflect the amount of an ingredient in a single dosage unit.