1Equipment and facility
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Inspection Record
BPI Labs, LLC — FDA 483 Findings
Inspectors Lisa R HilliardThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful and specific test methods.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Regulatory reporting and change control
Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.
About this record
Extracted automatically from the document US FDA published on 2026-05-27. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
