FDA posted five warning letters this week, including several from the Center for Tobacco. None are drug or device GMP warning letters. Now for the interesting part, two warning letters that we cover below were identified as posted on July 23rd. I think this may not be the case because I follow these so closely. So, for any of you who do the same, be cautious about putting too much faith in FDA’s posting dates for the warning letters. We cover two below, one as a compounding pharmacy, that were dated as being posted on July 23rd, but this is the first time I’ve seen them.
DRUGS | Scientific Solutions Global LLC
Scientific Solutions Global LLC (Carle Place, NY) received a warning letter on June 28, 2019. Based on the warning letter, the firm manufactures OTC drug products, some of which were deemed to be ‘new drugs.’ Deficiencies include but are not limited to:
- There is no system in place for testing and release of drug products before releasing for commercial distribution.
- Raw materials are accepted based on the supplier CoA, with no identity testing. The values on the CoA are not validated.
- The firm does not perform any process validation.
- The Quality Unit is inadequate because it does not ensure that product specifications are established and that product is tested before its release for distribution. Also, there is no stability program to ensure drugs meet their specifications thru expiry.
- Several of the drugs manufactured by the firm are deemed to be new drugs and are also misbranded.
COMPOUNDING PHARMACY | Westlab Pharmacy, Inc dba Westlab Pharmacy
Westlab Pharmacy, Inc dba Westlab Pharmacy received a warning letter on June 26, 2019, based on the outcome of an inspection ending August 15, 2018. Among the more interesting examples of adulteration was the use of non-pharmaceutical grade components, including but apparently not limited to “drinking alcohol,” in the production of injectable drugs. Drugs were also cited as being misbranded.