1Material and supplier control
You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B <Redacted B4> and 503B <Redacted B4> Specifically, you compound drug products that: a) are identical or nearly identical to an approved drug that is not on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing; or b) are not identical or nearly identical to an approved drug, but contain a bulk drug substance that is also a component of an approved drug, and for which there is no change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.
2Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l0) (A).
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, approval, and rejection ofcomponents.
4Training and personnel
Production personnel were not practicing good sanitation and health habits.
5Aseptic processing and sterility assurance
There are no established written methods of cleaning or methods of processing to remove pyrogenic properties.
6Labeling and packaging
The containers of your outsourcing facility's drug products does not include information required by section 503B (a)(lO)(B).
7Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity.
8Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
