1. Your firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).
Our investigator observed rodent feces throughout your facility:
- in direct proximity to the filling machine where you manufacture OTC drug products
- in direct proximity to the [redacted] system, which produces [redacted] incorporated in your drug products
- throughout the warehouse, around both raw materials and finished drug products
- Your over-the-counter [redacted] drug products include [redacted] ointments and [redacted].
...4. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188)."Hey, that's a FDA inspector - better keep altering that analytical report!" I would love to know the context behind that one.
Our investigator requested batch records for OTC drug product lots distributed to the United States, including [redacted] Ointment and [redacted]. You were unable to provide batch records.
In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for [redacted] Ointment lot (b)(4), although this lot had already been distributed to the U.S. market.