Looks like noones perfect, geez,
http://www.fda.gov/downloads/AboutF...cy/ORA/ORAElectronicReadingRoom/UCM478202.pdf
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1 "'·:".
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, the sterility test dated 9/10/15 which was conducted by your contract laboratory determined that Lipo-C Injectable, lot # 17478 (Production date: 8112/15, Beyond Use Date: 1/31/16) was not sterile. Subsequent speciation via dated 9/22/15 which was also performed by the contract laboratory determined that the contaminating organism was Streptomyces galbus. An investigation performed by the contracting laboratory dated 9/3/15 documented that the source of the contamination was caused by "external error". A second sample tested for sterility from the same lot passed sterility testing.
There was no documentation of an investigation by your firm into the initial failing sterility result or potential impact on lots of injectable drug products produced on the same date. For example, the following lots of injectable drug products were also produced on 8/12/15:
•••Glutathione, 200mg/ml, lot#17477
GHRP-2/GHRP-6/Sermorelin,lot # 17475
GHRP-2/GHRP-6/Sermorelin,lot #17473
OBSERVATION 2
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
A) Media Fills
SOP #T08.06 entitled, ''Sterile Compounding Process Validation " (Undated) documents, in part, that a total of[EJI*- will be used to conduct media fills.
1) Review of media fills conducted between 8/4/14 and 10/2/15 revealed that the media fills were not representative of actual production processes in that:
a. The media fills failed to simulate a lot with the maximum number of vials (i.e. (b) (4 )vials)b.
The number and type of interventions was not included (i.e. breaks in processing to clean up spillage)c. The aseptic assembly of equipment (e.g., at start-up, during processing) was not included.
d. The preparation/formulation of the API was not simulated.
2) Media fills for lyophilized products were not conducted (i.e. Human Chorionic Gonadotropin and Sermorelin)
B)Sterilizationto sterilize rubber stoppers, caps, andalcohol" tun.u;:n..uJ documents thathas not been performed to rt"'.'""'a""'t"'(b ) (4)
D ) LyophilizerYour firm utilizes a for the lyophilization of injectable drug products.Your firm failed to drug products such as Human ChorionicGonadotropin Lyophilized and Sermorelin used.
